Job Summary With more than 50+ years of consecutive growth, we've created a dynamic workplace where over 36,000 employees worldwide are empowered to grow and add to our entrepreneurial culture. To support our continued growth, we're looking to add new talent, like you, to our team! Our people are genuine, creative, and proactive problem solvers who have access to leadership for rapid alignment to make decisions driven by what's right for our customers. A Medline internship offers you real-world, hands-on experience where you can make a true impact. Interns take ownership of their projects and get a feel for day-to-day work in their respective roles. In addition to a typical Medline workday, the summer is jam-packed with enriching activities, such as social and networking events, leadership presentations, learning and development opportunities, community service projects, plus so much more. The tangible skillset you'll build while doing meaningful work will set you apart from your peers. Covering a variety of business areas and needs, our internships are available to rising seniors in undergraduate programs. Engineered for personal and professional development, our summer program runs for ten weeks from early June through mid-August. The Product Development Intern will support and coordinate product development activities between divisional stakeholders (Marketing, Clinical, Quality, etc.) and vendor partners. This intern will develop and communicate product requirements, evaluate product performance, and oversee development & production timelines.Job Description Possible projects could include: Develop product requirements, performance attributes, and quality specifications.Communicate to manufacturer through drawings and technical specs. Oversee product development timelines and communicate to divisional stakeholders and Vendors/Sourcing through utilization of Project Management software. Evaluate prototypes for usability, manufacturability, performance, and quality using analysis techniques such as visual evaluation, tactile textile evaluation, and creating testing plans/analyzing results. Administer process of approving new source to make an existing product by comparing all aspects of current product characteristics and performance to new potential source's prototype(s). Coordinate patent application process for SPT Division.Identify ideas that have potential for legal protection.Guide divisional stakeholders in patent process in order to maximize the full scope of intellectual property. Improve product quality and performance of existing products by working with internal quality team and manufacturing partners; develops custom methods to evaluate and improve product quality. Establish new product development sub-processes as needed to increase speed to market, reduce production and quality issues, etc. Create and update product technical specifications due to product improvements, evolving FDA requirements, and product changes due to Sourcing team needs. Utilize design software to create product drawings and communicate high-level ideas to factories. Qualifications: Pursuing a bachelor's degree in Engineering (Biomedical, Mechanical and Electrical preferred) Junior standing with a 3.0 minimum GPA preferred Experience in product development, sourcing, quality, industrial design, or engineering. Ability to manage multiple projects simultaneously. Experience in communicating with overseas manufacturing partners. Experience with design software such as SolidWorks Experience with MS Teams, Smartsheet, Minitab Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $23.25 - $32.50 HourlyThe actual salary will vary based on applicant's location, education, experience, skills, and abilities. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp for interns and temporary roles. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
09/13/2025
Full time
Job Summary With more than 50+ years of consecutive growth, we've created a dynamic workplace where over 36,000 employees worldwide are empowered to grow and add to our entrepreneurial culture. To support our continued growth, we're looking to add new talent, like you, to our team! Our people are genuine, creative, and proactive problem solvers who have access to leadership for rapid alignment to make decisions driven by what's right for our customers. A Medline internship offers you real-world, hands-on experience where you can make a true impact. Interns take ownership of their projects and get a feel for day-to-day work in their respective roles. In addition to a typical Medline workday, the summer is jam-packed with enriching activities, such as social and networking events, leadership presentations, learning and development opportunities, community service projects, plus so much more. The tangible skillset you'll build while doing meaningful work will set you apart from your peers. Covering a variety of business areas and needs, our internships are available to rising seniors in undergraduate programs. Engineered for personal and professional development, our summer program runs for ten weeks from early June through mid-August. The Product Development Intern will support and coordinate product development activities between divisional stakeholders (Marketing, Clinical, Quality, etc.) and vendor partners. This intern will develop and communicate product requirements, evaluate product performance, and oversee development & production timelines.Job Description Possible projects could include: Develop product requirements, performance attributes, and quality specifications.Communicate to manufacturer through drawings and technical specs. Oversee product development timelines and communicate to divisional stakeholders and Vendors/Sourcing through utilization of Project Management software. Evaluate prototypes for usability, manufacturability, performance, and quality using analysis techniques such as visual evaluation, tactile textile evaluation, and creating testing plans/analyzing results. Administer process of approving new source to make an existing product by comparing all aspects of current product characteristics and performance to new potential source's prototype(s). Coordinate patent application process for SPT Division.Identify ideas that have potential for legal protection.Guide divisional stakeholders in patent process in order to maximize the full scope of intellectual property. Improve product quality and performance of existing products by working with internal quality team and manufacturing partners; develops custom methods to evaluate and improve product quality. Establish new product development sub-processes as needed to increase speed to market, reduce production and quality issues, etc. Create and update product technical specifications due to product improvements, evolving FDA requirements, and product changes due to Sourcing team needs. Utilize design software to create product drawings and communicate high-level ideas to factories. Qualifications: Pursuing a bachelor's degree in Engineering (Biomedical, Mechanical and Electrical preferred) Junior standing with a 3.0 minimum GPA preferred Experience in product development, sourcing, quality, industrial design, or engineering. Ability to manage multiple projects simultaneously. Experience in communicating with overseas manufacturing partners. Experience with design software such as SolidWorks Experience with MS Teams, Smartsheet, Minitab Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $23.25 - $32.50 HourlyThe actual salary will vary based on applicant's location, education, experience, skills, and abilities. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp for interns and temporary roles. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Job Title Environmental Engineer/Consultant Job Type Full-time Career Level Mid Level Education Bachelor's Degree Location Orlando - Orlando, FL US (Primary) Category Professional Job Description PPM Consultants, Inc. (PPM), is seeking Environmental Engineers/Compliance Engineers and Scientists to work in our Orlando, Florida (Altamonte Springs) office. The ideal candidates have a Bachelor's degree in Engineering and a P.E. license in Florida. We are looking for candidates with 10-20 years of experience. This is a wonderful opportunity for self-starters who enjoy being part of a valuable team that provides multi-media environmental consulting and compliance support to a variety of industrial clients. Candidates will primarily provide environmental compliance, permitting and technical support to clients across several industries (Oil & Gas, Chemical, Manufacturing, Forest Products, etc.). Candidate will also be expected to prepare Remedial Action Plans and market PPM's services to clients. The position requires a strong work ethic, attention to detail, and effective scientific, marketing and communication skills. Responsibilities: • Prepare/evaluate environmental permit applications, emission reports, compliance certifications, etc. • Provide senior review of technical documents and applications and provide support to other engineering personnel • Manage projects and project teams • Evaluate and prepare Remedial Action Plans for petroleum underground storage tank cleanups • Interact with clients and assist them in maintaining compliance with applicable regulations • Communicate with regulators on permits and compliance issues • Participate in site visits, data collection, and investigations regarding environmental topics • Perform environmental calculations using appropriate methodologies • Lead/prepare proposals • Prepare environmental guidance documents and develop regulatory strategies • Market environmental compliance services Job Requirements Skills: • Extensive knowledge of EPA regulations • Familiarity with Florida, Georgia, Mississippi, Alabama, and Louisiana regulations are a plus • Familiarity and specialty in air compliance is a plus • Familiarity with the Florida PRP UST program is a plus • Knowledge of the Microsoft 365 Office Suite • Proficiency in Microsoft Excel • Ability to manage work product development and meet deadlines • Excellent written and verbal communications • Ability to handle information confidentially Education and Experience Requirements: • B.S. degree in Engineering or similar study with current professional licensure (Fl.) is preferred. • 10-20 years of environmental permitting, compliance and/or modeling experience; consulting experience preferred. • Knowledge of environmental compliance rules, regulations and agency structure in Florida and surrounding states PI090364e5-
09/12/2025
Full time
Job Title Environmental Engineer/Consultant Job Type Full-time Career Level Mid Level Education Bachelor's Degree Location Orlando - Orlando, FL US (Primary) Category Professional Job Description PPM Consultants, Inc. (PPM), is seeking Environmental Engineers/Compliance Engineers and Scientists to work in our Orlando, Florida (Altamonte Springs) office. The ideal candidates have a Bachelor's degree in Engineering and a P.E. license in Florida. We are looking for candidates with 10-20 years of experience. This is a wonderful opportunity for self-starters who enjoy being part of a valuable team that provides multi-media environmental consulting and compliance support to a variety of industrial clients. Candidates will primarily provide environmental compliance, permitting and technical support to clients across several industries (Oil & Gas, Chemical, Manufacturing, Forest Products, etc.). Candidate will also be expected to prepare Remedial Action Plans and market PPM's services to clients. The position requires a strong work ethic, attention to detail, and effective scientific, marketing and communication skills. Responsibilities: • Prepare/evaluate environmental permit applications, emission reports, compliance certifications, etc. • Provide senior review of technical documents and applications and provide support to other engineering personnel • Manage projects and project teams • Evaluate and prepare Remedial Action Plans for petroleum underground storage tank cleanups • Interact with clients and assist them in maintaining compliance with applicable regulations • Communicate with regulators on permits and compliance issues • Participate in site visits, data collection, and investigations regarding environmental topics • Perform environmental calculations using appropriate methodologies • Lead/prepare proposals • Prepare environmental guidance documents and develop regulatory strategies • Market environmental compliance services Job Requirements Skills: • Extensive knowledge of EPA regulations • Familiarity with Florida, Georgia, Mississippi, Alabama, and Louisiana regulations are a plus • Familiarity and specialty in air compliance is a plus • Familiarity with the Florida PRP UST program is a plus • Knowledge of the Microsoft 365 Office Suite • Proficiency in Microsoft Excel • Ability to manage work product development and meet deadlines • Excellent written and verbal communications • Ability to handle information confidentially Education and Experience Requirements: • B.S. degree in Engineering or similar study with current professional licensure (Fl.) is preferred. • 10-20 years of environmental permitting, compliance and/or modeling experience; consulting experience preferred. • Knowledge of environmental compliance rules, regulations and agency structure in Florida and surrounding states PI090364e5-
US Job Description Firm Information Reed Smith is a dynamic international law firm dedicated to helping clients move their businesses forward. With an inclusive culture and innovative mindset, we deliver smarter, more creative legal services that drive better outcomes for our clients. Our deep industry knowledge, long-standing relationships and collaborative structure make us the go-to partner for complex disputes, transactions and regulatory matters. Our team of 3,000 people (including more than 1,600 lawyers) across more than 30 offices in the United States, Europe, the Middle East and Asia, operate as one global partnership to drive progress for our clients, for ourselves and for our communities. Position Summary The Senior Solutions Architect in Legal Business Consulting will serve as a senior leader and trusted advisor, bridging the gap between client business needs, legal practice demands, and advanced technology solutions. This role combines the expertise of a solutions architect, sales engineer, and business transformation strategist, with a strong grounding in litigation support and corporate legal projects. The successful candidate will lead initiatives that transform how litigation and corporate legal departments leverage technology for efficiency, compliance, and strategic outcomes. They will not only design and deliver sophisticated solutions but also facilitate client workshops, lead global training programs, capture and integrate client feedback, and support business development through technical sales enablement. With 7-10 years of experience in consulting, legal technology, or adjacent industries-and a proven record in litigation support, corporate legal operations, and technology-enabled process transformation-this individual will drive high-impact outcomes for both clients and the firm. Job Duties and Responsibilities Client Engagement & Strategic Advisory Act as a senior advisor to litigation and corporate legal teams, aligning business challenges with practical, technology-enabled solutions. Lead client-facing workshops on AI, litigation management, matter lifecycle optimization, e-discovery, CLM, and legal operations strategy. Serve as a facilitator of client feedback loops, ensuring insights from litigation and corporate legal users inform product design and service delivery. Support business development efforts as a sales engineer, demonstrating solution capabilities for litigation support, regulatory risk, and transactional efficiency. Product Enablement, Demonstration & Training Design and deliver advanced, tailored demonstrations of legal technology platforms-including litigation management tools, CLM systems, e-discovery platforms, and AI-enabled applications. Lead global training initiatives for attorneys, litigation support staff, and corporate legal professionals. Partner with product vendors to refine offerings based on litigation and corporate law client requirements. Process Mapping & Business Transformation Collaborate with client legal departments and law firm practice groups to map and optimize litigation workflows, corporate contracting processes, and matter management systems. Apply expertise in process mapping methodologies to design scalable, repeatable solutions for corporate and litigation functions. Develop best practice frameworks for e-discovery readiness, contract lifecycle optimization, and corporate governance compliance. Project Leadership & Delivery Oversee complex, multi-workstream engagements across litigation and corporate legal projects. Provide leadership to cross-functional project teams, including Analysts, Architects, and Managers. Deliver executive-level communications and updates to senior client stakeholders, including GCs, CLOs, and litigation department heads. AI and Technology Drive implementation of AI and GenAI platforms tailored to litigation and corporate legal use cases. Identify opportunities for AI-assisted litigation strategy, workflow automation, and corporate transaction support. Operational Excellence & Team Leadership Contribute to continuous improvement of team methodologies, playbooks, and delivery frameworks. Mentor junior team members and foster a culture of , collaboration, and legal domain excellence. Represent the firm as a thought leader at client events, industry conferences, and forums on legal technology in litigation and corporate practice. Job duties and responsibilities included are not exhaustive and may be supplemented as necessary. Reed Smith reserves the right to revise or modify job duties and responsibilities at any time. Requirements Education: Bachelor's degree in Business, Computer Science, Industrial Engineering, Data Analysis, or related field required. Advanced degree or certifications (e.g., PMP, Lean Six Sigma, AI/ML, e-discovery certifications, IACCM for CLM) strongly preferred. Experience: 7-10 years of professional experience in consulting, legal technology, or business transformation roles. Significant experience delivering litigation technology solutions (e-discovery, case/matter management, analytics) and corporate legal technology solutions (CLM, governance, compliance). Demonstrated expertise in sales engineering, client training, process mapping, and leadership. Track record of implementing and scaling AI, CLM, and legal operations technology platforms. Skills: Exceptional written, verbal, and presentation skills; comfortable engaging with executive and attorney audiences. Deep knowledge of litigation workflows, corporate contracting processes, and legal operations best practices. Expertise in workshop facilitation, client engagement, and global training delivery. Strong analytical, project management, and leadership capabilities. Other Supervisory Responsibilities: May lead cross-functional teams and provide mentorship to junior staff. Equipment To Be Used: Personal computer and other office equipment such as telephone, calculator, fax, machine, copier, scanner, etc. Essential Job Functions: Ability to sit and/or stand for prolonged periods due to extensive computer use and meetings. Intense eye usage and finger, hand, and wrist dexterity for prolonged computer use (typing, mouse use). Proficient use of computers, telecommunication devices, and digital collaboration tools. Ability to accurately read and interpret written documents, computer screens, and other visual displays; sufficient visual acuity required. Ability to hear and understand verbal communication (conversations, instructions, phone and video calls) for effective collaboration. Demonstrated adaptability and resilience in a fast-paced, dynamic environment; maintain composure under pressure and respond effectively to change, including high-volume or unusual events. Exercise independent judgment and discretion in complex decision-making, adapting to changing priorities. Ability to self-manage tasks and deadlines in remote or hybrid settings, ensuring productivity and responsiveness without direct oversight. Ability to think critically and analyze complex situations, requiring sustained concentration. Capacity to learn and navigate complex legal technology platforms and tools, including those powered by advanced analytics or AI. Ability to synthesize complex project information into clear written documentation, including client-facing updates and reports. Maintain confidentiality and appropriately handle sensitive legal and client data. Willingness to occasionally work beyond normal hours in response to urgent or time-sensitive project demands. Working Conditions: Required to work in the office a minimum of 2 days per week; may occasionally require extended hours. Pay Ranges: This represents the presently-anticipated low and high end of Reed Smith's pay range for this position. Actual pay may vary based on various factors, including but not limited to location and experience. Pittsburgh, Houston, Dallas, Atlanta: $145,000 - $170,000 Chicago, Philadelphia: $150,000 - $170,000 Washington DC: $165,000 - $170,000 Employee Benefits Overview Our comprehensive benefits package includes: 401(k) Retirement Plan Medical Insurance Health Savings Account (HSA) Virtual Health Services Dental Insurance Vision Insurance Accident Insurance Hospital Indemnity Insurance Critical Illness Insurance Life Insurance Short-Term Disability Coverage Long-Term Disability Coverage Flexible Spending Accounts (FSA) Lyra Health Employee Assistance Program (EAP) Paid Family Leave (for eligible Exempt and Non-Exempt staff) College Savings Plan Transportation Benefit Back-up Child Care Services College Coach Program Pet Insurance Paid Sick Time (for Exempt staff) Paid Time Off (available to all full-time, non-temporary employees) Reed Smith offers a challenging work environment, business casual dress code and a total compensation package that includes a competitive salary, flexible benefits program, tuition assistance, and generous 401(k) plan. Reed Smith is an Equal Opportunity Employer with Core Values of Integrity, Excellence, Teamwork & Respect, Innovation, and Impact. Reed Smith also provides reasonable accommodations in accordance with law, including in the application and interview process. Qualified candidates only. No search firms.
09/11/2025
Full time
US Job Description Firm Information Reed Smith is a dynamic international law firm dedicated to helping clients move their businesses forward. With an inclusive culture and innovative mindset, we deliver smarter, more creative legal services that drive better outcomes for our clients. Our deep industry knowledge, long-standing relationships and collaborative structure make us the go-to partner for complex disputes, transactions and regulatory matters. Our team of 3,000 people (including more than 1,600 lawyers) across more than 30 offices in the United States, Europe, the Middle East and Asia, operate as one global partnership to drive progress for our clients, for ourselves and for our communities. Position Summary The Senior Solutions Architect in Legal Business Consulting will serve as a senior leader and trusted advisor, bridging the gap between client business needs, legal practice demands, and advanced technology solutions. This role combines the expertise of a solutions architect, sales engineer, and business transformation strategist, with a strong grounding in litigation support and corporate legal projects. The successful candidate will lead initiatives that transform how litigation and corporate legal departments leverage technology for efficiency, compliance, and strategic outcomes. They will not only design and deliver sophisticated solutions but also facilitate client workshops, lead global training programs, capture and integrate client feedback, and support business development through technical sales enablement. With 7-10 years of experience in consulting, legal technology, or adjacent industries-and a proven record in litigation support, corporate legal operations, and technology-enabled process transformation-this individual will drive high-impact outcomes for both clients and the firm. Job Duties and Responsibilities Client Engagement & Strategic Advisory Act as a senior advisor to litigation and corporate legal teams, aligning business challenges with practical, technology-enabled solutions. Lead client-facing workshops on AI, litigation management, matter lifecycle optimization, e-discovery, CLM, and legal operations strategy. Serve as a facilitator of client feedback loops, ensuring insights from litigation and corporate legal users inform product design and service delivery. Support business development efforts as a sales engineer, demonstrating solution capabilities for litigation support, regulatory risk, and transactional efficiency. Product Enablement, Demonstration & Training Design and deliver advanced, tailored demonstrations of legal technology platforms-including litigation management tools, CLM systems, e-discovery platforms, and AI-enabled applications. Lead global training initiatives for attorneys, litigation support staff, and corporate legal professionals. Partner with product vendors to refine offerings based on litigation and corporate law client requirements. Process Mapping & Business Transformation Collaborate with client legal departments and law firm practice groups to map and optimize litigation workflows, corporate contracting processes, and matter management systems. Apply expertise in process mapping methodologies to design scalable, repeatable solutions for corporate and litigation functions. Develop best practice frameworks for e-discovery readiness, contract lifecycle optimization, and corporate governance compliance. Project Leadership & Delivery Oversee complex, multi-workstream engagements across litigation and corporate legal projects. Provide leadership to cross-functional project teams, including Analysts, Architects, and Managers. Deliver executive-level communications and updates to senior client stakeholders, including GCs, CLOs, and litigation department heads. AI and Technology Drive implementation of AI and GenAI platforms tailored to litigation and corporate legal use cases. Identify opportunities for AI-assisted litigation strategy, workflow automation, and corporate transaction support. Operational Excellence & Team Leadership Contribute to continuous improvement of team methodologies, playbooks, and delivery frameworks. Mentor junior team members and foster a culture of , collaboration, and legal domain excellence. Represent the firm as a thought leader at client events, industry conferences, and forums on legal technology in litigation and corporate practice. Job duties and responsibilities included are not exhaustive and may be supplemented as necessary. Reed Smith reserves the right to revise or modify job duties and responsibilities at any time. Requirements Education: Bachelor's degree in Business, Computer Science, Industrial Engineering, Data Analysis, or related field required. Advanced degree or certifications (e.g., PMP, Lean Six Sigma, AI/ML, e-discovery certifications, IACCM for CLM) strongly preferred. Experience: 7-10 years of professional experience in consulting, legal technology, or business transformation roles. Significant experience delivering litigation technology solutions (e-discovery, case/matter management, analytics) and corporate legal technology solutions (CLM, governance, compliance). Demonstrated expertise in sales engineering, client training, process mapping, and leadership. Track record of implementing and scaling AI, CLM, and legal operations technology platforms. Skills: Exceptional written, verbal, and presentation skills; comfortable engaging with executive and attorney audiences. Deep knowledge of litigation workflows, corporate contracting processes, and legal operations best practices. Expertise in workshop facilitation, client engagement, and global training delivery. Strong analytical, project management, and leadership capabilities. Other Supervisory Responsibilities: May lead cross-functional teams and provide mentorship to junior staff. Equipment To Be Used: Personal computer and other office equipment such as telephone, calculator, fax, machine, copier, scanner, etc. Essential Job Functions: Ability to sit and/or stand for prolonged periods due to extensive computer use and meetings. Intense eye usage and finger, hand, and wrist dexterity for prolonged computer use (typing, mouse use). Proficient use of computers, telecommunication devices, and digital collaboration tools. Ability to accurately read and interpret written documents, computer screens, and other visual displays; sufficient visual acuity required. Ability to hear and understand verbal communication (conversations, instructions, phone and video calls) for effective collaboration. Demonstrated adaptability and resilience in a fast-paced, dynamic environment; maintain composure under pressure and respond effectively to change, including high-volume or unusual events. Exercise independent judgment and discretion in complex decision-making, adapting to changing priorities. Ability to self-manage tasks and deadlines in remote or hybrid settings, ensuring productivity and responsiveness without direct oversight. Ability to think critically and analyze complex situations, requiring sustained concentration. Capacity to learn and navigate complex legal technology platforms and tools, including those powered by advanced analytics or AI. Ability to synthesize complex project information into clear written documentation, including client-facing updates and reports. Maintain confidentiality and appropriately handle sensitive legal and client data. Willingness to occasionally work beyond normal hours in response to urgent or time-sensitive project demands. Working Conditions: Required to work in the office a minimum of 2 days per week; may occasionally require extended hours. Pay Ranges: This represents the presently-anticipated low and high end of Reed Smith's pay range for this position. Actual pay may vary based on various factors, including but not limited to location and experience. Pittsburgh, Houston, Dallas, Atlanta: $145,000 - $170,000 Chicago, Philadelphia: $150,000 - $170,000 Washington DC: $165,000 - $170,000 Employee Benefits Overview Our comprehensive benefits package includes: 401(k) Retirement Plan Medical Insurance Health Savings Account (HSA) Virtual Health Services Dental Insurance Vision Insurance Accident Insurance Hospital Indemnity Insurance Critical Illness Insurance Life Insurance Short-Term Disability Coverage Long-Term Disability Coverage Flexible Spending Accounts (FSA) Lyra Health Employee Assistance Program (EAP) Paid Family Leave (for eligible Exempt and Non-Exempt staff) College Savings Plan Transportation Benefit Back-up Child Care Services College Coach Program Pet Insurance Paid Sick Time (for Exempt staff) Paid Time Off (available to all full-time, non-temporary employees) Reed Smith offers a challenging work environment, business casual dress code and a total compensation package that includes a competitive salary, flexible benefits program, tuition assistance, and generous 401(k) plan. Reed Smith is an Equal Opportunity Employer with Core Values of Integrity, Excellence, Teamwork & Respect, Innovation, and Impact. Reed Smith also provides reasonable accommodations in accordance with law, including in the application and interview process. Qualified candidates only. No search firms.
Technology Program Manager Saint Paul, MN Direct Hire Overview: This position is responsible to work with BioMADE's technical program team on the full spectrum of activities associated with Program Management, ranging from conception of program calls to management of a portfolio of individual projects. This position is responsible to oversee reviewing and shepherding responses to project calls, and for justifying projects selected for funding, working closely with the BioMADE and U.S. Government leadership. This position will be responsible for the active management of a portfolio of BioMADE projects. The level of this position (junior/mid/senior) will be commensurate with the level of experience of the applicant. BioMADE is a Department of Defense sponsored institute and works closely with the department to identify and advance projects beneficial to national defense. Key Responsibilities: Manage a portfolio of BioMADE projects selected to advance bio-industrial manufacturing. Monitor technical progress, deliverables and milestones, and project related financial and intellectual property reporting. Utilize subject-matter expertise to guide and support project teams on submission quality and compliance with BioMADE procedural requirements. Integrate elements of the BioMADE Technology Roadmap into project calls. Conduct regular status meetings with project teams. Review and approve quarterly technical reports to ensure risks to the project are mitigated and projects are progressing. Review and approve final technical reports and post-award impact reports to identify project achievements to be shared publicly. (Senior Level) Identify relevant intellectual property landscape and risks based on reports from project teams and assist in technology transfer activities from project teams to other relevant organizations. Collaborate with the BioMADE Communications Team on publications, presentations, inventions, and other forms of intellectual property resulting from projects are being appropriately shared with BioMADE membership and external stakeholders, in accordance with BioMADE confidentiality provisions. Communicate project status updates, in coordination with the BioMADE Leadership Team (specifically the Chief Technology Officer and Workforce Development Team), to ensure the successful execution of the projects. Prepare project-related sections of the BioMADE annual plan, which details the technical projects, including milestones and deliverables, undertaken by BioMADE members on an annual basis. Prepare reports and associated documents for BioMADE leadership, committees, and DoD, to communicate status of the projects. Review and approve project invoices to ensure scope of work and deliverables are met. Ensure administrative and financial oversight of the projects are aligned with the technical progress. (Senior Level) Present on BioMADE and programmatic success to various stakeholders including the public through conferences, university talks, and other open venues. (Senior Level) Make recommendations to BioMADE IP Team regarding the project teams' development of their Intellectual Property Management Plan (IPMP) to ensure it complies with the BioMADE Intellectual Property paradigm, BioMADE Bylaws, and federal regulations. The IPMP is developed as part of the project award agreement to outline IP ownership, rights, use of background IP, and patent prosecution fees, among other related details. Conduct site visits to meet with the members working on their projects. Other duties as assigned. Requirements: Terminal Degree and 6+ years of relevant professional experience OR Bachelor's Degree or 10+ years' experience. Preferred qualifications are degrees related to bioindustrial manufacturing including, but not limited to: bioengineering, chemical engineering, microbiology, chemistry, biochemistry, and business. Training or experience in business management including , but not limited to, PMP or Lean Six Sigma certification, or MBA a plus. Ability to resolve complex problems/issues and to make administrative/procedural decisions and judgments. Effective communication skills, with evidence of strength of technical and persuasive writing. Experience in critical review and evaluation of scientific content. Ability to collect, analyze and interpret data and information from various sources. Broad experience in biotech and engineering, bioprocess development and optimization, molecular and synthetic biology, metabolic engineering and strain construction, pharmaceutical fermentation production, biopolymers and biomaterials, modeling of cell metabolism, and bioprocess simulations. Ability to travel up to 50% time. Job Requirements: Program Manager
02/27/2022
Full time
Technology Program Manager Saint Paul, MN Direct Hire Overview: This position is responsible to work with BioMADE's technical program team on the full spectrum of activities associated with Program Management, ranging from conception of program calls to management of a portfolio of individual projects. This position is responsible to oversee reviewing and shepherding responses to project calls, and for justifying projects selected for funding, working closely with the BioMADE and U.S. Government leadership. This position will be responsible for the active management of a portfolio of BioMADE projects. The level of this position (junior/mid/senior) will be commensurate with the level of experience of the applicant. BioMADE is a Department of Defense sponsored institute and works closely with the department to identify and advance projects beneficial to national defense. Key Responsibilities: Manage a portfolio of BioMADE projects selected to advance bio-industrial manufacturing. Monitor technical progress, deliverables and milestones, and project related financial and intellectual property reporting. Utilize subject-matter expertise to guide and support project teams on submission quality and compliance with BioMADE procedural requirements. Integrate elements of the BioMADE Technology Roadmap into project calls. Conduct regular status meetings with project teams. Review and approve quarterly technical reports to ensure risks to the project are mitigated and projects are progressing. Review and approve final technical reports and post-award impact reports to identify project achievements to be shared publicly. (Senior Level) Identify relevant intellectual property landscape and risks based on reports from project teams and assist in technology transfer activities from project teams to other relevant organizations. Collaborate with the BioMADE Communications Team on publications, presentations, inventions, and other forms of intellectual property resulting from projects are being appropriately shared with BioMADE membership and external stakeholders, in accordance with BioMADE confidentiality provisions. Communicate project status updates, in coordination with the BioMADE Leadership Team (specifically the Chief Technology Officer and Workforce Development Team), to ensure the successful execution of the projects. Prepare project-related sections of the BioMADE annual plan, which details the technical projects, including milestones and deliverables, undertaken by BioMADE members on an annual basis. Prepare reports and associated documents for BioMADE leadership, committees, and DoD, to communicate status of the projects. Review and approve project invoices to ensure scope of work and deliverables are met. Ensure administrative and financial oversight of the projects are aligned with the technical progress. (Senior Level) Present on BioMADE and programmatic success to various stakeholders including the public through conferences, university talks, and other open venues. (Senior Level) Make recommendations to BioMADE IP Team regarding the project teams' development of their Intellectual Property Management Plan (IPMP) to ensure it complies with the BioMADE Intellectual Property paradigm, BioMADE Bylaws, and federal regulations. The IPMP is developed as part of the project award agreement to outline IP ownership, rights, use of background IP, and patent prosecution fees, among other related details. Conduct site visits to meet with the members working on their projects. Other duties as assigned. Requirements: Terminal Degree and 6+ years of relevant professional experience OR Bachelor's Degree or 10+ years' experience. Preferred qualifications are degrees related to bioindustrial manufacturing including, but not limited to: bioengineering, chemical engineering, microbiology, chemistry, biochemistry, and business. Training or experience in business management including , but not limited to, PMP or Lean Six Sigma certification, or MBA a plus. Ability to resolve complex problems/issues and to make administrative/procedural decisions and judgments. Effective communication skills, with evidence of strength of technical and persuasive writing. Experience in critical review and evaluation of scientific content. Ability to collect, analyze and interpret data and information from various sources. Broad experience in biotech and engineering, bioprocess development and optimization, molecular and synthetic biology, metabolic engineering and strain construction, pharmaceutical fermentation production, biopolymers and biomaterials, modeling of cell metabolism, and bioprocess simulations. Ability to travel up to 50% time. Job Requirements: Program Manager
Director of Strategy Would you like to shape our marketing & business strategy for the future of energy? Are you passionate, intellectually curious, and creative? Join our forward-thinking Marketing & Strategy Team Bringing the most cutting-edge physical and digital technologies together to create oilfield equipment is the beating heart of our work. Devising smarter systems that control and monitor oil and gas extraction, our subsea and flexible pipe capabilities are industry-leading and commercially innovative. Shape the future The Director of Strategy will head up the marketing and strategy function globally for out Flexible Pipe Systems (Offshore) business. Along with performing core functions, you will be working with the Senior Management team to assist a key business achieving its growth ambitions. As Director of Strategy, you will be responsible for: Developing and updating the marketing forecast (timing, size of award etc.) through analysis, with relevant details including new market/industry segments. This includes tracking all FPS Onshore awards as they happen to update our database and to use as inputs to additional analysis Leading and delivering timely and accurate market analysis and insights (market, competition & customer intelligence, and analysis) - with a clear focus on the medium to long-term trends, looking beyond the immediate opportunities/tenders Assessing competitor strategy and performance and developing insights about customer priorities and future plans; evaluating implications for OFE & Baker Hughes and make recommendations; synthesizing inputs related to market intelligence from regions/functions/product lines Working closely with product managers to assist in the development of new products/solutions and enhancements to existing product/solutions in alignment with market needs; developing and updating value propositions as well as proof points Participating in priority deal reviews and contribute as required Delivering elements of strategic planning processes (e.g. annual strategic plan / LRP - Long Range Plan, portfolio analysis, capital allocation etc.) Drive LRP tracking after review. Leading/participating in strategic projects - e.g., evaluation of potential new markets/products, realignment of businesses, market assessment of potential acquisitions Working with Sales & Commercial team to assist in the development of new products/solutions & enhancements to existing product/solutions in alignment with market needs Collaborating with colleagues in other functions, regions and OFE businesses to translate insights and strategic plans to practical business actions Drafting the key messages (including but, not limited to value propositions) in collaboration with other functions and provide the content for Marketing material (product catalogues, brochures etc.) Disseminating knowledge internally through presentations, webchats, written communications Demonstrating thought leadership and represent Baker Hughes externally e.g., publishing papers or speaking at appropriate conferences and seminars, in meetings with regulators and potential partners Managing or contributing to relevant internal databases (market shares, installed base etc.) Other activities that fall within the remit of the OFE Marketing and Strategy team Fuel your passion To be successful in this role you will have: Bachelor's degree from an accredited university or college 5+ years of experience in one or more of: Oil & Gas industry (operator or equipment/service company) strategy consulting industrial marketing/strategy Strong upstream oil and gas industry knowledge and relevant experience, preferably in the onshore segments - especially in US Land. Demonstrated ability of driving business development through segment/customer /region penetration strategies Excellent analytics and problem-solving, including ability to form hypotheses and move forward in the absence of complete information Excellent oral and written communication skills, including ability to synthesize complex topics into clear, simple and crisp messages Fluent in written and spoken English Interpersonal skills to work well with colleagues across all businesses/cultures, achieve objectives through effective influencing, and establish credibility with senior leaders Ability to learn relevant tools (Salesforce.com & 3rd party market research databases) quickly; proficiency in MS Office and Excel. Desired Characteristics Following characteristics are relevant and useful to the role but, not mandatory: Degree in engineering MBA or advanced degree in science/engineering Experience in the onshore upstream and midstream oil and gas sector and/or RTP business. Working with us Our people are at the heart of what we do at Baker Hughes. We know we are better when all of our people are developed, engaged and able to bring their whole authentic selves to work. We invest in the health and well-being of our workforce, train and reward talent and develop leaders at all levels to bring out the best in each other. Working for you Our inventions have revolutionized energy for over a century. But to keep going forward tomorrow, we know we have to push the boundaries today. We prioritize rewarding those who embrace change with a package that reflects how much we value their input. Join us, and you can expect: Contemporary work-life balance policies and wellbeing activities Comprehensive private medical care options Safety net of life insurance and disability programs Tailored financial programs Additional elected or voluntary benefits About Us With operations in over 120 countries, we provide better solutions for our customers and richer opportunities for our people. As a leading partner to the energy industry, we're committed to achieving net-zero carbon emissions by 2050 and we're always looking for the right people to help us get there. People who are as passionate as we are about making energy safer, cleaner and more efficient. Join Us Are you seeking an opportunity to make a real difference in a company with a global reach and exciting services and clients? Come join us and grow with a team of people who will energize and inspire you! About Us: With operations in over 120 countries, we provide better solutions for our customers and richer opportunities for our people. As a leading partner to the energy industry, we're committed to achieving net-zero carbon emissions by 2050 and we're always looking for the right people to help us get there. People who are as passionate as we are about making energy safer, cleaner and more efficient. Join Us: Are you seeking an opportunity to make a real difference in a company that values innovation and progress? Join us and become part of a team of people who will challenge and inspire you! Let's come together and take energy forward. Baker Hughes Company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
02/18/2022
Full time
Director of Strategy Would you like to shape our marketing & business strategy for the future of energy? Are you passionate, intellectually curious, and creative? Join our forward-thinking Marketing & Strategy Team Bringing the most cutting-edge physical and digital technologies together to create oilfield equipment is the beating heart of our work. Devising smarter systems that control and monitor oil and gas extraction, our subsea and flexible pipe capabilities are industry-leading and commercially innovative. Shape the future The Director of Strategy will head up the marketing and strategy function globally for out Flexible Pipe Systems (Offshore) business. Along with performing core functions, you will be working with the Senior Management team to assist a key business achieving its growth ambitions. As Director of Strategy, you will be responsible for: Developing and updating the marketing forecast (timing, size of award etc.) through analysis, with relevant details including new market/industry segments. This includes tracking all FPS Onshore awards as they happen to update our database and to use as inputs to additional analysis Leading and delivering timely and accurate market analysis and insights (market, competition & customer intelligence, and analysis) - with a clear focus on the medium to long-term trends, looking beyond the immediate opportunities/tenders Assessing competitor strategy and performance and developing insights about customer priorities and future plans; evaluating implications for OFE & Baker Hughes and make recommendations; synthesizing inputs related to market intelligence from regions/functions/product lines Working closely with product managers to assist in the development of new products/solutions and enhancements to existing product/solutions in alignment with market needs; developing and updating value propositions as well as proof points Participating in priority deal reviews and contribute as required Delivering elements of strategic planning processes (e.g. annual strategic plan / LRP - Long Range Plan, portfolio analysis, capital allocation etc.) Drive LRP tracking after review. Leading/participating in strategic projects - e.g., evaluation of potential new markets/products, realignment of businesses, market assessment of potential acquisitions Working with Sales & Commercial team to assist in the development of new products/solutions & enhancements to existing product/solutions in alignment with market needs Collaborating with colleagues in other functions, regions and OFE businesses to translate insights and strategic plans to practical business actions Drafting the key messages (including but, not limited to value propositions) in collaboration with other functions and provide the content for Marketing material (product catalogues, brochures etc.) Disseminating knowledge internally through presentations, webchats, written communications Demonstrating thought leadership and represent Baker Hughes externally e.g., publishing papers or speaking at appropriate conferences and seminars, in meetings with regulators and potential partners Managing or contributing to relevant internal databases (market shares, installed base etc.) Other activities that fall within the remit of the OFE Marketing and Strategy team Fuel your passion To be successful in this role you will have: Bachelor's degree from an accredited university or college 5+ years of experience in one or more of: Oil & Gas industry (operator or equipment/service company) strategy consulting industrial marketing/strategy Strong upstream oil and gas industry knowledge and relevant experience, preferably in the onshore segments - especially in US Land. Demonstrated ability of driving business development through segment/customer /region penetration strategies Excellent analytics and problem-solving, including ability to form hypotheses and move forward in the absence of complete information Excellent oral and written communication skills, including ability to synthesize complex topics into clear, simple and crisp messages Fluent in written and spoken English Interpersonal skills to work well with colleagues across all businesses/cultures, achieve objectives through effective influencing, and establish credibility with senior leaders Ability to learn relevant tools (Salesforce.com & 3rd party market research databases) quickly; proficiency in MS Office and Excel. Desired Characteristics Following characteristics are relevant and useful to the role but, not mandatory: Degree in engineering MBA or advanced degree in science/engineering Experience in the onshore upstream and midstream oil and gas sector and/or RTP business. Working with us Our people are at the heart of what we do at Baker Hughes. We know we are better when all of our people are developed, engaged and able to bring their whole authentic selves to work. We invest in the health and well-being of our workforce, train and reward talent and develop leaders at all levels to bring out the best in each other. Working for you Our inventions have revolutionized energy for over a century. But to keep going forward tomorrow, we know we have to push the boundaries today. We prioritize rewarding those who embrace change with a package that reflects how much we value their input. Join us, and you can expect: Contemporary work-life balance policies and wellbeing activities Comprehensive private medical care options Safety net of life insurance and disability programs Tailored financial programs Additional elected or voluntary benefits About Us With operations in over 120 countries, we provide better solutions for our customers and richer opportunities for our people. As a leading partner to the energy industry, we're committed to achieving net-zero carbon emissions by 2050 and we're always looking for the right people to help us get there. People who are as passionate as we are about making energy safer, cleaner and more efficient. Join Us Are you seeking an opportunity to make a real difference in a company with a global reach and exciting services and clients? Come join us and grow with a team of people who will energize and inspire you! About Us: With operations in over 120 countries, we provide better solutions for our customers and richer opportunities for our people. As a leading partner to the energy industry, we're committed to achieving net-zero carbon emissions by 2050 and we're always looking for the right people to help us get there. People who are as passionate as we are about making energy safer, cleaner and more efficient. Join Us: Are you seeking an opportunity to make a real difference in a company that values innovation and progress? Join us and become part of a team of people who will challenge and inspire you! Let's come together and take energy forward. Baker Hughes Company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Description Job Description: Leidos has an immediate opening for a Group Security Director to lead the Leidos Intelligence Group enterprise security organization. This position is responsible for envisioning and aligning security's contribution to the Intelligence Group's strategic growth objectives and customer requirements. The successful candidate should have a deep understanding of the US Intelligence Community and its associated industrial and information assurance regulatory framework with the demonstrated capability to align those competencies to support business growth in the areas of intelligence analysis and operations, applied tradecraft, and systems development and modernization. The Intelligence Group Security Director also serves as a strategic advisor to the Group President and operations staff for personnel security clearance reform, clearance and classified facility reciprocity and growth enablement. Primary responsibilities include but are not limited to: •Understands the vision and direction of the Intelligence Group President; formulates, executes and oversees plans and objectives to support that direction; integrates plans at the strategic and operational level of the supported organization •Leads, manages and directs subordinate and matrixed security staff in support of Intelligence Group business objectives while aligning the overall security effort with the broader Leidos security enterprise; measures performance, develops the organization as needed to support the Intelligence group including staff professional competencies •Develops innovative approaches to solve complex and novel challenges consistent with corporate and customer risk appetite while maintaining excellence in regulatory and contractual compliance •Actively manages threats to and vulnerabilities within the Intelligence Group in conjunction with Corporate Insider Risk Management, Emergency Management, Counterintelligence, and International Security programs •Implements and provides guidance to management on security issues such as security education, classified document control, security investigations, classification control, classified construction standards, and personnel clearances •Directs the analysis of security breaches and disciplinary actions related to security violations and incidents within the Intelligence Group; prepares reports of findings, implements remediation and risk mitigations consistent with those findings IMPACT: •Directs activities that have a significant impact on the achievement of results for the security function and across the Intelligence Group; frequently influences decisions made by leadership. •Decisions within the function and advice to leadership drives long-term success, failure, profitability, and growth through security infrastructure and cleared personnel planning •Establishes and implements strategic and operational plans with associated budgets, for the security department and enabling plans for the Intelligence Group operational functions with a significant impact on the overall success of the Leidos enterprise security organization •Work requires a high degree of creative thinking, independence of coordinated action with a keen sense of personal responsibility and accountability for results COMPLEXITY: •Problems and issues faced are complex, unique to circumstance and customer preferences and require consideration of variables that have enterprise-wide impact •Conducts extensive investigation and analysis to understand the root cause of problems factoring in customer requirements, national security responsibilities and business exigencies •Problems are highly complex and typically involve multiple functions, projects, or customers in a multi-agency regulatory environment COMMUNICATION: •Communicates and negotiates with senior management officials within and outside of Leidos on matters of strategic importance •Requires the ability to prepare and deliver succinct executive briefings and correspondence reducing complex issues to actionable recommendations delivered with credibility and impact •Negotiates and influences others to understand and accept new concepts, practices, and approaches LEADERSHIP & TALENT MANAGEMENT: •Manages organizations that encompass multiple teams led by managers and supervisors •Develops mid to long-term plans on optimizing the Intelligence Security Group and the talent required to execute strategies for the job area. •Hires, terminates, promotes and reward performance in accordance with organizational guidelines. KNOWLEDGE: •Requires in-depth management and leadership knowledge to lead teams or manage across multiple functions within Leidos •Requires in-depth knowledge of Intelligence Community Directives (ICDs) •Requires advanced business knowledge in intelligence support functions, advanced management and leadership capability •Required working knowledge of supporting merger and acquisition activities and associated organizational integration tasks TYPICAL EDUCATION & EXPERIENCE: •Broad practical experience across multiple security professional disciplines within the organization, combining theory, past practical experience, and the organization's business practices •Requires a BA/BS and 15+ years of prior relevant experience, BA/BS in a relevant field is preferred •Must have 12+ years of experience supervising of leading teams or projects in progressively challenging assignments at least one of which is functionally equivalent to this position •Demonstrated mastery of executive level briefings, prior experience managing organizational budgets and large projects External Referral Bonus: Eligible Potential for Telework: Yes, 10% Clearance Level Required: Top Secret/SCI Travel: Yes, 10% of the time Scheduled Weekly Hours: 40 Shift: Day Requisition Category: Manager Job Family: Security Pay Range: Leidos is a Fortune 500 ® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 38,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit . Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here . Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to . All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
03/17/2021
Full time
Description Job Description: Leidos has an immediate opening for a Group Security Director to lead the Leidos Intelligence Group enterprise security organization. This position is responsible for envisioning and aligning security's contribution to the Intelligence Group's strategic growth objectives and customer requirements. The successful candidate should have a deep understanding of the US Intelligence Community and its associated industrial and information assurance regulatory framework with the demonstrated capability to align those competencies to support business growth in the areas of intelligence analysis and operations, applied tradecraft, and systems development and modernization. The Intelligence Group Security Director also serves as a strategic advisor to the Group President and operations staff for personnel security clearance reform, clearance and classified facility reciprocity and growth enablement. Primary responsibilities include but are not limited to: •Understands the vision and direction of the Intelligence Group President; formulates, executes and oversees plans and objectives to support that direction; integrates plans at the strategic and operational level of the supported organization •Leads, manages and directs subordinate and matrixed security staff in support of Intelligence Group business objectives while aligning the overall security effort with the broader Leidos security enterprise; measures performance, develops the organization as needed to support the Intelligence group including staff professional competencies •Develops innovative approaches to solve complex and novel challenges consistent with corporate and customer risk appetite while maintaining excellence in regulatory and contractual compliance •Actively manages threats to and vulnerabilities within the Intelligence Group in conjunction with Corporate Insider Risk Management, Emergency Management, Counterintelligence, and International Security programs •Implements and provides guidance to management on security issues such as security education, classified document control, security investigations, classification control, classified construction standards, and personnel clearances •Directs the analysis of security breaches and disciplinary actions related to security violations and incidents within the Intelligence Group; prepares reports of findings, implements remediation and risk mitigations consistent with those findings IMPACT: •Directs activities that have a significant impact on the achievement of results for the security function and across the Intelligence Group; frequently influences decisions made by leadership. •Decisions within the function and advice to leadership drives long-term success, failure, profitability, and growth through security infrastructure and cleared personnel planning •Establishes and implements strategic and operational plans with associated budgets, for the security department and enabling plans for the Intelligence Group operational functions with a significant impact on the overall success of the Leidos enterprise security organization •Work requires a high degree of creative thinking, independence of coordinated action with a keen sense of personal responsibility and accountability for results COMPLEXITY: •Problems and issues faced are complex, unique to circumstance and customer preferences and require consideration of variables that have enterprise-wide impact •Conducts extensive investigation and analysis to understand the root cause of problems factoring in customer requirements, national security responsibilities and business exigencies •Problems are highly complex and typically involve multiple functions, projects, or customers in a multi-agency regulatory environment COMMUNICATION: •Communicates and negotiates with senior management officials within and outside of Leidos on matters of strategic importance •Requires the ability to prepare and deliver succinct executive briefings and correspondence reducing complex issues to actionable recommendations delivered with credibility and impact •Negotiates and influences others to understand and accept new concepts, practices, and approaches LEADERSHIP & TALENT MANAGEMENT: •Manages organizations that encompass multiple teams led by managers and supervisors •Develops mid to long-term plans on optimizing the Intelligence Security Group and the talent required to execute strategies for the job area. •Hires, terminates, promotes and reward performance in accordance with organizational guidelines. KNOWLEDGE: •Requires in-depth management and leadership knowledge to lead teams or manage across multiple functions within Leidos •Requires in-depth knowledge of Intelligence Community Directives (ICDs) •Requires advanced business knowledge in intelligence support functions, advanced management and leadership capability •Required working knowledge of supporting merger and acquisition activities and associated organizational integration tasks TYPICAL EDUCATION & EXPERIENCE: •Broad practical experience across multiple security professional disciplines within the organization, combining theory, past practical experience, and the organization's business practices •Requires a BA/BS and 15+ years of prior relevant experience, BA/BS in a relevant field is preferred •Must have 12+ years of experience supervising of leading teams or projects in progressively challenging assignments at least one of which is functionally equivalent to this position •Demonstrated mastery of executive level briefings, prior experience managing organizational budgets and large projects External Referral Bonus: Eligible Potential for Telework: Yes, 10% Clearance Level Required: Top Secret/SCI Travel: Yes, 10% of the time Scheduled Weekly Hours: 40 Shift: Day Requisition Category: Manager Job Family: Security Pay Range: Leidos is a Fortune 500 ® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 38,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit . Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here . Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to . All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
ABOUT US Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product. WHO ARE WE Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE . Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are A gile, L eading, I nnovating, V alue Creating, and E ngaging. We embrace our challenges as opportunities. We are empowered to think and act. We never settle; we strive to improve through purposeful creativity. We build aligned teams who learn, grow, and deliver. We are committed to building strong relationships. Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today! JOB SUMMARY The Manager, Plasmid Planning, maintains a holistic view of plasmid manufacturing activity for the operating site, ensuring manufacturing planning functions as the "control tower" providing all planning and reporting required to enable operational success; maximizing OTIF performance and customer satisfaction by managing the creation, maintenance, and evaluation of all manufacturing plans, and proposing and escalating required management interventions addressing constraints and trends across all facets of manufacturing planning and performance. This role leads site plasmid planning activity and is responsible for continuously assessing and improving the capability and robustness of all planning processes in a low volume, repetitive, make to order environment to effectively operate and minimize risk to the business while maximizing operational performance and stakeholder satisfaction throughout the site and network. Operates cross-functionally to actively shape and drive the development and execution of metrics, analyses, new process implementation, and process improvement. This is a managerial role for a single site and reports to the Head of Supply Chain ESSENTIAL JOB FUNCTIONS Develop, administer, maintain, and improve end-to-end manufacturing planning processes, including, but not limited to, supply planning, master scheduling, material and inventory planning, capacity planning, and operational reporting. Lead planning in the evolution from startup to a fully integrated systems approach, recognizing short and mid-term gaps and vulnerabilities, and mitigating associated risks by rapidly standing up and maturing planning processes. Develop and maintain planning and operational KPIs measuring the operating health of the site and its ability to meet short-term and ongoing customer expectations and financial objectives. Alert cross-functional stakeholders and the management chain of command to all observed issues, their potential implications, and formulate, drive and escalate required countermeasures as needed. Work collaboratively with Manufacturing, Process Development, and Technology Transfer; establishing schedules to meet contractual obligations and to create and maintain bills of materials for manufacturing, process development, and technology transfer campaigns. Monitor the manufacturing, process development, and technology transfer schedules as they relate to raw material inventory and consumption and ensure raw materials are procured and on-hand to ensure on-time delivery of production schedules. Collaborate daily with Manufacturing, Supply Chain, Quality Control, and Quality to resolve raw material issues, scheduling conflicts, inventory levels, and delivery requirements. Develop raw material supply and quality risk assessments for all BOM items, create risk mitigation plans for high-risk materials, and execute risk mitigation plans to ensure uninterrupted drug/material supply. Develop an inventory policy based on supply chain risk and manage demand forecasting, raw material and inventory planning, and raw material and safety stock levels to prevent manufacturing or development delays in a highly complex environment managing multiple BOMs, WIPs, and technology platforms. Work cross-functionally with manufacturing and process development to model various scenarios facilitating go/no-go decisions. Experience and Skills EDUCATION AND/ OR EXPERIENCE Bachelor's degree in Supply Chain, Operations, Business, Industrial Engineering, or related field; Master's degree in Supply Chain, Operations Management, or Business Administration (MBA) preferred Seven years of experience in supply chain or manufacturing planning and operations Five years of demonstrated people management experience Advanced knowledge in supply planning (Master Production Scheduling, Materials Requirement Planning, Capacity Planning) processes with demonstrated experience building, standing up, and maturing end-to-end manufacturing planning processes Advanced ERP skills; Microsoft Dynamics preferred, or Tier 1 experience in Oracle or SAP Advanced analytical skills using purpose-built statistical software, i.e., Minitab or JMP, Access, or Excel, including complex pivoting and data mining Certified in production and inventory management or supply chain management; APICS CPIM, CSCP, or ISM CPSM preferred Lean, Six Sigma, or Lean Six Sigma credentials preferred; green belt or higher Expertise functioning within a formal business management system such as Toyota, Danaher, Ingersoll Rand, Honeywell or similar structured methodology preferred Prior cGMP regulated experience in pharmaceutical or biotechnology industry a plus Manufacturing and supply chain acumen. Direct experience with a consistent record of demonstrating significant, quantifiable success and achievement in complex manufacturing and supply chain environments is essential. Business partner. Maintains a strong commercial orientation and a proven ability to partner with line managers and operating teams to drive and monitor performance and to develop strategic plans that elevate process and operational performance. Leadership presence. Comfortable being uncomfortable, consistently displaying sound judgment, and a passion for excellence, with a solution focus, promoting process improvement across the site. Ability to interact with the site and senior management in a manner that instills confidence and respect at all levels of the organization. Effectively Consumes Data. Good at identifying trends and interpreting data with a clear ability to connect the dots; understanding how behavior and decisions in any part of the system influence overall system dynamics. Examines scenarios from multiple perspectives, asks the right questions to gain additional insights, understands potential implications in a fact-based manner, and formulates and drives appropriate interventions and countermeasures. Acts with urgency. Instinctively takes the initiative while thoroughly understanding and operating in the context of the big picture, key drivers, and what we can accomplish; relentlessly pursues rapid improvement and excellence over a crawl toward perceived perfection. Owner's mentality. Embraces accountability and maintains an owner's mindset - takes action: see something, say something, do something; protects and promotes culture, protects and grows the business, and develops others. Attention to detail. Displays accuracy and precision in the creation of all deliverables and in carrying out all facets of responsibility. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle. Communicate using telephone and e-mail.
03/07/2021
Full time
ABOUT US Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product. WHO ARE WE Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE . Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are A gile, L eading, I nnovating, V alue Creating, and E ngaging. We embrace our challenges as opportunities. We are empowered to think and act. We never settle; we strive to improve through purposeful creativity. We build aligned teams who learn, grow, and deliver. We are committed to building strong relationships. Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today! JOB SUMMARY The Manager, Plasmid Planning, maintains a holistic view of plasmid manufacturing activity for the operating site, ensuring manufacturing planning functions as the "control tower" providing all planning and reporting required to enable operational success; maximizing OTIF performance and customer satisfaction by managing the creation, maintenance, and evaluation of all manufacturing plans, and proposing and escalating required management interventions addressing constraints and trends across all facets of manufacturing planning and performance. This role leads site plasmid planning activity and is responsible for continuously assessing and improving the capability and robustness of all planning processes in a low volume, repetitive, make to order environment to effectively operate and minimize risk to the business while maximizing operational performance and stakeholder satisfaction throughout the site and network. Operates cross-functionally to actively shape and drive the development and execution of metrics, analyses, new process implementation, and process improvement. This is a managerial role for a single site and reports to the Head of Supply Chain ESSENTIAL JOB FUNCTIONS Develop, administer, maintain, and improve end-to-end manufacturing planning processes, including, but not limited to, supply planning, master scheduling, material and inventory planning, capacity planning, and operational reporting. Lead planning in the evolution from startup to a fully integrated systems approach, recognizing short and mid-term gaps and vulnerabilities, and mitigating associated risks by rapidly standing up and maturing planning processes. Develop and maintain planning and operational KPIs measuring the operating health of the site and its ability to meet short-term and ongoing customer expectations and financial objectives. Alert cross-functional stakeholders and the management chain of command to all observed issues, their potential implications, and formulate, drive and escalate required countermeasures as needed. Work collaboratively with Manufacturing, Process Development, and Technology Transfer; establishing schedules to meet contractual obligations and to create and maintain bills of materials for manufacturing, process development, and technology transfer campaigns. Monitor the manufacturing, process development, and technology transfer schedules as they relate to raw material inventory and consumption and ensure raw materials are procured and on-hand to ensure on-time delivery of production schedules. Collaborate daily with Manufacturing, Supply Chain, Quality Control, and Quality to resolve raw material issues, scheduling conflicts, inventory levels, and delivery requirements. Develop raw material supply and quality risk assessments for all BOM items, create risk mitigation plans for high-risk materials, and execute risk mitigation plans to ensure uninterrupted drug/material supply. Develop an inventory policy based on supply chain risk and manage demand forecasting, raw material and inventory planning, and raw material and safety stock levels to prevent manufacturing or development delays in a highly complex environment managing multiple BOMs, WIPs, and technology platforms. Work cross-functionally with manufacturing and process development to model various scenarios facilitating go/no-go decisions. Experience and Skills EDUCATION AND/ OR EXPERIENCE Bachelor's degree in Supply Chain, Operations, Business, Industrial Engineering, or related field; Master's degree in Supply Chain, Operations Management, or Business Administration (MBA) preferred Seven years of experience in supply chain or manufacturing planning and operations Five years of demonstrated people management experience Advanced knowledge in supply planning (Master Production Scheduling, Materials Requirement Planning, Capacity Planning) processes with demonstrated experience building, standing up, and maturing end-to-end manufacturing planning processes Advanced ERP skills; Microsoft Dynamics preferred, or Tier 1 experience in Oracle or SAP Advanced analytical skills using purpose-built statistical software, i.e., Minitab or JMP, Access, or Excel, including complex pivoting and data mining Certified in production and inventory management or supply chain management; APICS CPIM, CSCP, or ISM CPSM preferred Lean, Six Sigma, or Lean Six Sigma credentials preferred; green belt or higher Expertise functioning within a formal business management system such as Toyota, Danaher, Ingersoll Rand, Honeywell or similar structured methodology preferred Prior cGMP regulated experience in pharmaceutical or biotechnology industry a plus Manufacturing and supply chain acumen. Direct experience with a consistent record of demonstrating significant, quantifiable success and achievement in complex manufacturing and supply chain environments is essential. Business partner. Maintains a strong commercial orientation and a proven ability to partner with line managers and operating teams to drive and monitor performance and to develop strategic plans that elevate process and operational performance. Leadership presence. Comfortable being uncomfortable, consistently displaying sound judgment, and a passion for excellence, with a solution focus, promoting process improvement across the site. Ability to interact with the site and senior management in a manner that instills confidence and respect at all levels of the organization. Effectively Consumes Data. Good at identifying trends and interpreting data with a clear ability to connect the dots; understanding how behavior and decisions in any part of the system influence overall system dynamics. Examines scenarios from multiple perspectives, asks the right questions to gain additional insights, understands potential implications in a fact-based manner, and formulates and drives appropriate interventions and countermeasures. Acts with urgency. Instinctively takes the initiative while thoroughly understanding and operating in the context of the big picture, key drivers, and what we can accomplish; relentlessly pursues rapid improvement and excellence over a crawl toward perceived perfection. Owner's mentality. Embraces accountability and maintains an owner's mindset - takes action: see something, say something, do something; protects and promotes culture, protects and grows the business, and develops others. Attention to detail. Displays accuracy and precision in the creation of all deliverables and in carrying out all facets of responsibility. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle. Communicate using telephone and e-mail.
Job ID : 98905 Leonardo Daylight Solutions business provides industry-changing mid-infrared laser light technology for government and commercial markets, including: defense and security; life sciences; and industrial process control. As a mid-IR technology pioneer, Daylight Solutions has delivered more mid-IR systems to more applications world-wide than any other company. Job Summary When you're part of the DRS Daylight Solutions team, you'll do important work, like giving customers cutting edge tools to diagnosing and fight cancer. Your work will have real-world impact, and you'll be supported in achieving your career goals. How will you make an impact? The position will work with a cross-functional business and technology team to drive the identification, pursuit and acquisition of strategic business opportunities including commercial and R&D partnerships, alliances, joint ventures, licensing and acquisitions that support the business strategy. Job Responsibilities New account acquisition and the expansion of existing accounts within an emerging Life Sciences instrumentation business. Expand and grow business base by developing new customer relationships Manage all phases of the business development cycle to successfully close, including opportunity development, proposal development, implementation estimating, project scoping, client presentations, negotiation and close. Build and establish long-term relationships with senior leaders in medical device manufacturers and professional organizations. Translate customer needs into relevant deliverables that leverage the firm's products, technologies and services Collaborates cross-functionally with team members (Business GMs, Product Management, Research & Development, Finance, Legal and others as needed) in support of assessing and closing new business opportunities. Job Responsibilities Part II Leads, directs and is responsible for day-to-day management of deals with potential partners. Drives projects through cross-functional teams. Holds team members accountable for deliverables. Responsible for developing the business case and presenting it to senior management Close early sales for new products and markets considered strategic for business advancement Build early sales pipeline Drives all communications and negotiations with potential partners Provides clear, concise project updates to all levels in the organization. Work with internal product development teams to coordinate with external partners. Interacts with key thought leaders and customers in the industry to keep up with science and proactively look for potential opportunities. How will you get here? Qualifications Bachelor's degree in marketing or engineering or related discipline or equivalent combination of education and experience Master's degree preferred Understanding of US Contracting and budgeting processes Strong interpersonal verbal, written, and presentation skills Excellent planning and organization, project management, and time management skills Ability to work on extremely complex problems Advanced knowledge of Company products, markets and technology Job Requirements:
01/29/2021
Full time
Job ID : 98905 Leonardo Daylight Solutions business provides industry-changing mid-infrared laser light technology for government and commercial markets, including: defense and security; life sciences; and industrial process control. As a mid-IR technology pioneer, Daylight Solutions has delivered more mid-IR systems to more applications world-wide than any other company. Job Summary When you're part of the DRS Daylight Solutions team, you'll do important work, like giving customers cutting edge tools to diagnosing and fight cancer. Your work will have real-world impact, and you'll be supported in achieving your career goals. How will you make an impact? The position will work with a cross-functional business and technology team to drive the identification, pursuit and acquisition of strategic business opportunities including commercial and R&D partnerships, alliances, joint ventures, licensing and acquisitions that support the business strategy. Job Responsibilities New account acquisition and the expansion of existing accounts within an emerging Life Sciences instrumentation business. Expand and grow business base by developing new customer relationships Manage all phases of the business development cycle to successfully close, including opportunity development, proposal development, implementation estimating, project scoping, client presentations, negotiation and close. Build and establish long-term relationships with senior leaders in medical device manufacturers and professional organizations. Translate customer needs into relevant deliverables that leverage the firm's products, technologies and services Collaborates cross-functionally with team members (Business GMs, Product Management, Research & Development, Finance, Legal and others as needed) in support of assessing and closing new business opportunities. Job Responsibilities Part II Leads, directs and is responsible for day-to-day management of deals with potential partners. Drives projects through cross-functional teams. Holds team members accountable for deliverables. Responsible for developing the business case and presenting it to senior management Close early sales for new products and markets considered strategic for business advancement Build early sales pipeline Drives all communications and negotiations with potential partners Provides clear, concise project updates to all levels in the organization. Work with internal product development teams to coordinate with external partners. Interacts with key thought leaders and customers in the industry to keep up with science and proactively look for potential opportunities. How will you get here? Qualifications Bachelor's degree in marketing or engineering or related discipline or equivalent combination of education and experience Master's degree preferred Understanding of US Contracting and budgeting processes Strong interpersonal verbal, written, and presentation skills Excellent planning and organization, project management, and time management skills Ability to work on extremely complex problems Advanced knowledge of Company products, markets and technology Job Requirements:
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Director of Process & Platform Operations is a key leadership position within Sana Technical Operations as we prepare to advance a pipeline of next-generation gene and cell therapy products to the clinic. The role will lead and build a team of production associates, engineers and scientists to provide technical leadership to establish operations for production and supply of material from research through Phase 1 GMP for novel gene therapy (viral vector) products. The team, led by this role, will establish efficient production operations to supply early research material supply, critical materials (GLP tox), and enable GMP supply by leading tech transfer to GMP manufacturing. The role has technical accountability and oversight for supply of materials from internal or external (CMO) GMP facilities, partnering with process development, analytical, and GMP manufacturing teams. The role will engage in Sana's enterprise-level manufacturing and supply chain planning, including the build out of internal GMP capabilities and external supply chain networks. In this capacity, the Leader will contribute to line-of-sight for life cycle management, with focus on process/technology improvements to the platform and assessment of product comparability. With a strong focus on both technical and operational excellence, this senior hands-on managerial position will play a leading role in shaping core production technology platforms at Sana and the advancement of therapeutic gene therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advanced therapies. DUTIES AND RESPONSIBILITIES The leader will oversee activities in support of early supply of quality research materials to guide pre-clinical candidate selection. With a mindset toward accelerating development, the leader will embrace both science and manufacturability to define and operationalize efficient production platforms for material supply across the early development horizon from candidate selection through to Phase 1 IND. The leader in this role will manage an operations team to supply early research, pilot scale supply and GLP study material supply, tech transfer and process establishment in GMP. The leader will participate with process and analytical development in early process characterization with an eye toward de-risking and troubleshooting production operations, use of scaledown models, and new manufacturing technology exploration. The role will be a member of the Manufacturing network leadership team and will contribute to and influence gene therapy manufacturing and network strategies, and standards for both drug substance and drug product production. The role will work closely with Process & Analytical Development, Quality, External Manufacturing, Supply Chain and CMC/product lifecycle teams to advance our pipeline and establish a robust development network for new products. The role will be viewed as a technical thought leader internally and externally in manufacturing viral vectors and complex biologics. The successful candidate will have industrial experience managing a process development team for biologics/vaccines (and/or preferably gene/cell therapy) and manufacturing operations, have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing and growing team. Responsibilities: Establish scientifically-sound and operationally-efficient production workflows for supply of quality research-grade viral vectors for early research studies. Oversee a research production capability to support production of novel viral vector compositions for research customers, perform early optimization & manufacturability assessments, manage a lean industrial workflow to supply small-volume and high-quality vectors in line with business/customer expectations of turnaround time and capacity. Establish the requirements for the clinical manufacturing process for viral vector and ensure application of these requirements throughout the product life cycle. Leveraging a platform mindset to achieve speed and efficiency, establish processes at scale and define an approach for rapid introduction of new candidates. Be accountable for technical success of process operations in the supply of GLP and GMP material. Identify opportunities to shape both the technology platform and manufacturing operations to build a platform within Sana to increase speed, gain efficiency, increase probability of success of supply, reduce cost, and ensure quality in meeting program deliverables across the Sana portfolio of programs. As with other advanced therapies, critical attention to raw materials is a key consideration. Transfer processes developed to internal/external manufacturing sites. This includes ensuring clear definition of the clinical manufacturing control strategy and associated enabling documents/validation or supporting technical studies. Advise on developmental studies needed to ensure successful transfer and de-risking of clinical operations. Engage with Process & Analytical Development to ensure sound process qualification, control and comparability strategies are in place to support the programs. Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy for vector technologies. Participate in the CMO selection process by evaluating CMO capabilities against technical requirements. Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply. Participate in appropriate internal and joint CMO governance meetings (ex, joint steering committees). Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers Hire and manage a team of scientists to define, operationalize, and maintain production workflows. Contribute to build-out of early product and process insights. With a focus on technical excellence, the individual will oversee production activities and their: implementation, performance, troubleshooting, and trending. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications and provide technical leadership in review of content for regulatory interactions. QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of bioprocess principals and practice; a technical and people leader with experience managing department(s) with mid-level and senior employees. Experience with the following cell culture, purification, chromatography, clarification technologies, tangential flow and normal filtration, aseptic processing and drug product, process automation, high-throughput process development, automated liquid handling, electronic notebooks. Prior experience leading a team in Process Development, pilot scale production, tech transfer, and/or GMP manufacturing is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in process development and operations for complex biological products.
01/27/2021
Full time
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Director of Process & Platform Operations is a key leadership position within Sana Technical Operations as we prepare to advance a pipeline of next-generation gene and cell therapy products to the clinic. The role will lead and build a team of production associates, engineers and scientists to provide technical leadership to establish operations for production and supply of material from research through Phase 1 GMP for novel gene therapy (viral vector) products. The team, led by this role, will establish efficient production operations to supply early research material supply, critical materials (GLP tox), and enable GMP supply by leading tech transfer to GMP manufacturing. The role has technical accountability and oversight for supply of materials from internal or external (CMO) GMP facilities, partnering with process development, analytical, and GMP manufacturing teams. The role will engage in Sana's enterprise-level manufacturing and supply chain planning, including the build out of internal GMP capabilities and external supply chain networks. In this capacity, the Leader will contribute to line-of-sight for life cycle management, with focus on process/technology improvements to the platform and assessment of product comparability. With a strong focus on both technical and operational excellence, this senior hands-on managerial position will play a leading role in shaping core production technology platforms at Sana and the advancement of therapeutic gene therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advanced therapies. DUTIES AND RESPONSIBILITIES The leader will oversee activities in support of early supply of quality research materials to guide pre-clinical candidate selection. With a mindset toward accelerating development, the leader will embrace both science and manufacturability to define and operationalize efficient production platforms for material supply across the early development horizon from candidate selection through to Phase 1 IND. The leader in this role will manage an operations team to supply early research, pilot scale supply and GLP study material supply, tech transfer and process establishment in GMP. The leader will participate with process and analytical development in early process characterization with an eye toward de-risking and troubleshooting production operations, use of scaledown models, and new manufacturing technology exploration. The role will be a member of the Manufacturing network leadership team and will contribute to and influence gene therapy manufacturing and network strategies, and standards for both drug substance and drug product production. The role will work closely with Process & Analytical Development, Quality, External Manufacturing, Supply Chain and CMC/product lifecycle teams to advance our pipeline and establish a robust development network for new products. The role will be viewed as a technical thought leader internally and externally in manufacturing viral vectors and complex biologics. The successful candidate will have industrial experience managing a process development team for biologics/vaccines (and/or preferably gene/cell therapy) and manufacturing operations, have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing and growing team. Responsibilities: Establish scientifically-sound and operationally-efficient production workflows for supply of quality research-grade viral vectors for early research studies. Oversee a research production capability to support production of novel viral vector compositions for research customers, perform early optimization & manufacturability assessments, manage a lean industrial workflow to supply small-volume and high-quality vectors in line with business/customer expectations of turnaround time and capacity. Establish the requirements for the clinical manufacturing process for viral vector and ensure application of these requirements throughout the product life cycle. Leveraging a platform mindset to achieve speed and efficiency, establish processes at scale and define an approach for rapid introduction of new candidates. Be accountable for technical success of process operations in the supply of GLP and GMP material. Identify opportunities to shape both the technology platform and manufacturing operations to build a platform within Sana to increase speed, gain efficiency, increase probability of success of supply, reduce cost, and ensure quality in meeting program deliverables across the Sana portfolio of programs. As with other advanced therapies, critical attention to raw materials is a key consideration. Transfer processes developed to internal/external manufacturing sites. This includes ensuring clear definition of the clinical manufacturing control strategy and associated enabling documents/validation or supporting technical studies. Advise on developmental studies needed to ensure successful transfer and de-risking of clinical operations. Engage with Process & Analytical Development to ensure sound process qualification, control and comparability strategies are in place to support the programs. Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy for vector technologies. Participate in the CMO selection process by evaluating CMO capabilities against technical requirements. Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply. Participate in appropriate internal and joint CMO governance meetings (ex, joint steering committees). Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers Hire and manage a team of scientists to define, operationalize, and maintain production workflows. Contribute to build-out of early product and process insights. With a focus on technical excellence, the individual will oversee production activities and their: implementation, performance, troubleshooting, and trending. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications and provide technical leadership in review of content for regulatory interactions. QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of bioprocess principals and practice; a technical and people leader with experience managing department(s) with mid-level and senior employees. Experience with the following cell culture, purification, chromatography, clarification technologies, tangential flow and normal filtration, aseptic processing and drug product, process automation, high-throughput process development, automated liquid handling, electronic notebooks. Prior experience leading a team in Process Development, pilot scale production, tech transfer, and/or GMP manufacturing is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in process development and operations for complex biological products.
Alion Science and Technology Corporation
Tobyhanna, Pennsylvania
Alion's expertise in wireless communication is unrivaled. This includes 50+ years' of experience performing complex RF Engineering analysis for DoD customers, civilian government agencies, and commercial companies worldwide. Our expertise in collecting, analyzing, and formatting spectrum data, including RF measurement, frequency assignment, spectrum certification, LiDAR, and other geo-referenced data, enables us to produce refined RF modeling and simulation tools and applications with the reliability and precision needed to assure spectrum access and control. Alion's analysis-driven tools support diverse tasks such as spectrum forensics and deconfliction, testing for coverage amid urban clutter, and antenna site planning. Alion's Radio Frequency and Electromagnetic Spectrum Engineering Directorate (RESED) offers a variety of work, from projects supporting international satellite coordination to countering IEDs. Our work is increasingly important in a world that depends on well-coordinated, interference-free spectrum access. Alion is seeking a Production Engineer/Program Manager to be located at Tobyhanna Army Depot, PA. Successful candidate will have significant prior experience at Tobyhanna, as well as management and technical experience. Detailed knowledge of Tobyhanna facility operations and business opportunities strongly preferred. Flexible work schedule and hours available; some of the duties may be able to be performed via a telecommute arrangement. This position requires expertise in the areas of production engineering, program management and business development. Duties and Responsibilities Production Engineering: Conceives, investigates, evaluates, and makes recommendations for new equipment, tooling and processes to improve safety, reliability, capacity and reduce costs. Performs complex analysis, design, and/or assembly related to manufacturing or industrial engineering projects. Investigates and analyzes unique or highly technical manufacturing or industrial engineering assignments and provides technical assistance in establishing operational procedures and methods. Performs technical surveillance of a complex nature in the control of product, design concepts, and specification requirements. Evaluates engineering changes and determines appropriate labor or equipment standards to meet specification requirements. Utilizes systematic problem solving and data collection to identify and resolve problems, including driving cost and downtime reduction. Leads and/or participates in health, safety, environmental, production, material control, Six Sigma and R&D project teams. Writes weekly activity and project reports, develops action plans, and generates work instructions, test procedures and other documentation to support production operations. Program Management: Manages the project in order to expand Alion's participation, anticipating and meeting customer needs; directs the tactical activities of the program including, but not limited to, engineering, finance and operations with the objective of maximizing growth and profitability. Seeks to build project revenue by remaining alert to new business opportunities or expansion of business with the customer and advising senior operations management. Conducts briefings and technical meetings for senior company and customer management. Interacts with peer managers concerning matters of significance to the company. Exerts influence in developing overall project objectives to ensure that the project is completed on schedule and within budget. Ensures adherence to Alion administrative policies and procedures, human resource policies and practices as applicable, and contracts administration procedures that support the programs of Alion, and ensures that the contract is administered to protect Alion's interest and comply with all applicable laws and regulations. Directs efforts to improve the quality and efficiency of the Alion team through training and development programs in both technical and scientific disciplines. Business Development: Develops key business relationships in the government marketplace, with a primary responsibility for identifying and developing opportunities for business expansion. Supports the development of customer or market penetration strategies and individual opportunity win strategies, account plans, technology development plans, and partnering strategies. Acts as liaison with government agencies and offices. Ensures that the business development strategy is implemented. Maintains extensive knowledge of the current developments in the government marketplace in order to assess the position of company and determines how to improve it. Makes recommendations for change or modification to strategy. May lead teams in order to develop and deliver various professional services solutions to include whitepapers, demonstrations, proposals and other internally developed products used to identify, qualify and capture new business. Qualifications Bachelor's degree in related field plus 10 years or Master's plus 8 years related experience. At least 2 years project management experience, plus 3 years supervisory/management experience. In some cases, educational requirements may be adjusted or waived for more than 20 years applicable work experience. Work experience may be adjusted for highly specialized knowledge or uniquely applicable experience for positions involving new technology or labor market shortages as reflected by market survey data. Prior work experience at Tobyhanna Army Depot is required. Extensive knowledge of Tobyhanna Army Depot business and operations. Technical and management experience strongly desired. A security clearance of an appropriate level may be required after employment. US Citizenship is required #LI-JK1 *CJ Security Clearance: None
01/25/2021
Full time
Alion's expertise in wireless communication is unrivaled. This includes 50+ years' of experience performing complex RF Engineering analysis for DoD customers, civilian government agencies, and commercial companies worldwide. Our expertise in collecting, analyzing, and formatting spectrum data, including RF measurement, frequency assignment, spectrum certification, LiDAR, and other geo-referenced data, enables us to produce refined RF modeling and simulation tools and applications with the reliability and precision needed to assure spectrum access and control. Alion's analysis-driven tools support diverse tasks such as spectrum forensics and deconfliction, testing for coverage amid urban clutter, and antenna site planning. Alion's Radio Frequency and Electromagnetic Spectrum Engineering Directorate (RESED) offers a variety of work, from projects supporting international satellite coordination to countering IEDs. Our work is increasingly important in a world that depends on well-coordinated, interference-free spectrum access. Alion is seeking a Production Engineer/Program Manager to be located at Tobyhanna Army Depot, PA. Successful candidate will have significant prior experience at Tobyhanna, as well as management and technical experience. Detailed knowledge of Tobyhanna facility operations and business opportunities strongly preferred. Flexible work schedule and hours available; some of the duties may be able to be performed via a telecommute arrangement. This position requires expertise in the areas of production engineering, program management and business development. Duties and Responsibilities Production Engineering: Conceives, investigates, evaluates, and makes recommendations for new equipment, tooling and processes to improve safety, reliability, capacity and reduce costs. Performs complex analysis, design, and/or assembly related to manufacturing or industrial engineering projects. Investigates and analyzes unique or highly technical manufacturing or industrial engineering assignments and provides technical assistance in establishing operational procedures and methods. Performs technical surveillance of a complex nature in the control of product, design concepts, and specification requirements. Evaluates engineering changes and determines appropriate labor or equipment standards to meet specification requirements. Utilizes systematic problem solving and data collection to identify and resolve problems, including driving cost and downtime reduction. Leads and/or participates in health, safety, environmental, production, material control, Six Sigma and R&D project teams. Writes weekly activity and project reports, develops action plans, and generates work instructions, test procedures and other documentation to support production operations. Program Management: Manages the project in order to expand Alion's participation, anticipating and meeting customer needs; directs the tactical activities of the program including, but not limited to, engineering, finance and operations with the objective of maximizing growth and profitability. Seeks to build project revenue by remaining alert to new business opportunities or expansion of business with the customer and advising senior operations management. Conducts briefings and technical meetings for senior company and customer management. Interacts with peer managers concerning matters of significance to the company. Exerts influence in developing overall project objectives to ensure that the project is completed on schedule and within budget. Ensures adherence to Alion administrative policies and procedures, human resource policies and practices as applicable, and contracts administration procedures that support the programs of Alion, and ensures that the contract is administered to protect Alion's interest and comply with all applicable laws and regulations. Directs efforts to improve the quality and efficiency of the Alion team through training and development programs in both technical and scientific disciplines. Business Development: Develops key business relationships in the government marketplace, with a primary responsibility for identifying and developing opportunities for business expansion. Supports the development of customer or market penetration strategies and individual opportunity win strategies, account plans, technology development plans, and partnering strategies. Acts as liaison with government agencies and offices. Ensures that the business development strategy is implemented. Maintains extensive knowledge of the current developments in the government marketplace in order to assess the position of company and determines how to improve it. Makes recommendations for change or modification to strategy. May lead teams in order to develop and deliver various professional services solutions to include whitepapers, demonstrations, proposals and other internally developed products used to identify, qualify and capture new business. Qualifications Bachelor's degree in related field plus 10 years or Master's plus 8 years related experience. At least 2 years project management experience, plus 3 years supervisory/management experience. In some cases, educational requirements may be adjusted or waived for more than 20 years applicable work experience. Work experience may be adjusted for highly specialized knowledge or uniquely applicable experience for positions involving new technology or labor market shortages as reflected by market survey data. Prior work experience at Tobyhanna Army Depot is required. Extensive knowledge of Tobyhanna Army Depot business and operations. Technical and management experience strongly desired. A security clearance of an appropriate level may be required after employment. US Citizenship is required #LI-JK1 *CJ Security Clearance: None
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description • Under general supervision supports utilities operations (plant and clean utility, ethanol, HVAC) • Ensures operations comply with cGMP and company standards for quality, health, safety and the environment • Investigates plant failures and operating incidents, determines cause and recommends and implements solutions • Analyzes maintenance history, waste and energy usage and process models and recommends improvement plans • Provides technical support, project briefs, system requirements and preliminary budgets for facility modifications, upgrades and capital projects • Maintains quality standards, risk assessments and CSL standard operating procedures (SOPs) Position Purpose: The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Play an essential leadership role in the operation and troubleshooting of the clean utility systems. Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Position Qualifications and Experience Requirements: Education Bachelor's Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience Experience working in a Union environment is preferred but not required. Must have experience with leading mid-to-large capital projects for the pharmaceutical industry. Experience in new facility start-up, large scale equipment package vendor management, and FAT execution and coordination. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. Knowledge of CIP/SIP, clean room design/requirements. Working knowledge of pharmaceutical process sanitary connections, valves and supply loops. Working knowledge of Process Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required. Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.) Knowledge & experience in the design, implementation, operations and maintenance of clean utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Ability to write technical reports and to develop data gathering schedules. Ability to work on technical specifications and procurement details. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Knowledge of building management systems (Emerson, Rockwell) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness
01/20/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description • Under general supervision supports utilities operations (plant and clean utility, ethanol, HVAC) • Ensures operations comply with cGMP and company standards for quality, health, safety and the environment • Investigates plant failures and operating incidents, determines cause and recommends and implements solutions • Analyzes maintenance history, waste and energy usage and process models and recommends improvement plans • Provides technical support, project briefs, system requirements and preliminary budgets for facility modifications, upgrades and capital projects • Maintains quality standards, risk assessments and CSL standard operating procedures (SOPs) Position Purpose: The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Play an essential leadership role in the operation and troubleshooting of the clean utility systems. Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Position Qualifications and Experience Requirements: Education Bachelor's Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience Experience working in a Union environment is preferred but not required. Must have experience with leading mid-to-large capital projects for the pharmaceutical industry. Experience in new facility start-up, large scale equipment package vendor management, and FAT execution and coordination. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. Knowledge of CIP/SIP, clean room design/requirements. Working knowledge of pharmaceutical process sanitary connections, valves and supply loops. Working knowledge of Process Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required. Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.) Knowledge & experience in the design, implementation, operations and maintenance of clean utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Ability to write technical reports and to develop data gathering schedules. Ability to work on technical specifications and procurement details. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Knowledge of building management systems (Emerson, Rockwell) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness
Minimum Required Skills: Controls Engineer, Baggage Handling, Electrical Engineering, Electrical Engineer, PLC If you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please read on! What You Will Be Doing Participate in electrical control design and commissioning. Follow Our standards in electrical controls design, PLC programming and commissioning. Essential Duties and Responsibilities " Understand project schedule and objectives. " Understand project requirements by studying project specifications, customer requirements, and performance standards. " Follow standards in electrical controls design, PLC programming and commissioning. " Contribute to team effort by participating in assigned engineering activities. " Communicate with project engineer and/or project manager regarding progress or problems related to the project. " Confirm product performance by conducting verification tests. " Ensure quality on all engineering deliverables. " Keep standardization high and constantly improve processes. " Keep current with technology. " Any other task as directed by management. Responsibility and Authority " Responsibility: Noted above. Complete assigned tasks on time and within allocated budget while maintaining high output quality, customer satisfaction, engineering process, engineering quality. " Authority: Engineering technical decisions within spec compliance Qualifications " B.S. Electrical Engineering or equivalent combination of education and experience. " Strong analytical, verbal, and written communications skills. Experience " 3+ years controls experience. " Experience designing controls systems, commissioning, and troubleshooting PLC industrial control systems (e.g. Rockwell, Square D, and Siemens) and their industrial networks (e.g. ControlNet, DeviceNet, Modbus, Profibus, and Ethernet). " Competency with field installation supervision, monitoring Electrical installation subcontractors, and closing of jobs What You Need for this Position - Controls Engineer - Baggage Handling - Electrical Engineering - Electrical Engineer - PLCSo, if you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please apply today! Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume! Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume! CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved. - provided by Dice
10/01/2020
Full time
Minimum Required Skills: Controls Engineer, Baggage Handling, Electrical Engineering, Electrical Engineer, PLC If you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please read on! What You Will Be Doing Participate in electrical control design and commissioning. Follow Our standards in electrical controls design, PLC programming and commissioning. Essential Duties and Responsibilities " Understand project schedule and objectives. " Understand project requirements by studying project specifications, customer requirements, and performance standards. " Follow standards in electrical controls design, PLC programming and commissioning. " Contribute to team effort by participating in assigned engineering activities. " Communicate with project engineer and/or project manager regarding progress or problems related to the project. " Confirm product performance by conducting verification tests. " Ensure quality on all engineering deliverables. " Keep standardization high and constantly improve processes. " Keep current with technology. " Any other task as directed by management. Responsibility and Authority " Responsibility: Noted above. Complete assigned tasks on time and within allocated budget while maintaining high output quality, customer satisfaction, engineering process, engineering quality. " Authority: Engineering technical decisions within spec compliance Qualifications " B.S. Electrical Engineering or equivalent combination of education and experience. " Strong analytical, verbal, and written communications skills. Experience " 3+ years controls experience. " Experience designing controls systems, commissioning, and troubleshooting PLC industrial control systems (e.g. Rockwell, Square D, and Siemens) and their industrial networks (e.g. ControlNet, DeviceNet, Modbus, Profibus, and Ethernet). " Competency with field installation supervision, monitoring Electrical installation subcontractors, and closing of jobs What You Need for this Position - Controls Engineer - Baggage Handling - Electrical Engineering - Electrical Engineer - PLCSo, if you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please apply today! Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume! Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume! CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved. - provided by Dice
Minimum Required Skills: Controls Engineer, Baggage Handling, Electrical Engineering, Electrical Engineer, PLC If you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please read on! What You Will Be Doing Participate in electrical control design and commissioning. Follow Our standards in electrical controls design, PLC programming and commissioning. Essential Duties and Responsibilities " Understand project schedule and objectives. " Understand project requirements by studying project specifications, customer requirements, and performance standards. " Follow standards in electrical controls design, PLC programming and commissioning. " Contribute to team effort by participating in assigned engineering activities. " Communicate with project engineer and/or project manager regarding progress or problems related to the project. " Confirm product performance by conducting verification tests. " Ensure quality on all engineering deliverables. " Keep standardization high and constantly improve processes. " Keep current with technology. " Any other task as directed by management. Responsibility and Authority " Responsibility: Noted above. Complete assigned tasks on time and within allocated budget while maintaining high output quality, customer satisfaction, engineering process, engineering quality. " Authority: Engineering technical decisions within spec compliance Qualifications " B.S. Electrical Engineering or equivalent combination of education and experience. " Strong analytical, verbal, and written communications skills. Experience " 3+ years controls experience. " Experience designing controls systems, commissioning, and troubleshooting PLC industrial control systems (e.g. Rockwell, Square D, and Siemens) and their industrial networks (e.g. ControlNet, DeviceNet, Modbus, Profibus, and Ethernet). " Competency with field installation supervision, monitoring Electrical installation subcontractors, and closing of jobs What You Need for this Position - Controls Engineer - Baggage Handling - Electrical Engineering - Electrical Engineer - PLCSo, if you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please apply today! Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume! Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume! CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved. - provided by Dice
10/01/2020
Full time
Minimum Required Skills: Controls Engineer, Baggage Handling, Electrical Engineering, Electrical Engineer, PLC If you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please read on! What You Will Be Doing Participate in electrical control design and commissioning. Follow Our standards in electrical controls design, PLC programming and commissioning. Essential Duties and Responsibilities " Understand project schedule and objectives. " Understand project requirements by studying project specifications, customer requirements, and performance standards. " Follow standards in electrical controls design, PLC programming and commissioning. " Contribute to team effort by participating in assigned engineering activities. " Communicate with project engineer and/or project manager regarding progress or problems related to the project. " Confirm product performance by conducting verification tests. " Ensure quality on all engineering deliverables. " Keep standardization high and constantly improve processes. " Keep current with technology. " Any other task as directed by management. Responsibility and Authority " Responsibility: Noted above. Complete assigned tasks on time and within allocated budget while maintaining high output quality, customer satisfaction, engineering process, engineering quality. " Authority: Engineering technical decisions within spec compliance Qualifications " B.S. Electrical Engineering or equivalent combination of education and experience. " Strong analytical, verbal, and written communications skills. Experience " 3+ years controls experience. " Experience designing controls systems, commissioning, and troubleshooting PLC industrial control systems (e.g. Rockwell, Square D, and Siemens) and their industrial networks (e.g. ControlNet, DeviceNet, Modbus, Profibus, and Ethernet). " Competency with field installation supervision, monitoring Electrical installation subcontractors, and closing of jobs What You Need for this Position - Controls Engineer - Baggage Handling - Electrical Engineering - Electrical Engineer - PLCSo, if you are a Material Handling Controls Engineer- Mid-Senior Level with experience, please apply today! Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume! Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume! CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved. - provided by Dice
