Title- Equipment Commissioning Specialist Duration- 12+ months Location- Warren, NJ Pay range- $50 to $53.00/hr This role supports the successful operation of facilities, laboratories, and business functions at multi use sites through interaction with internal team members and peer level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Facilities and Utilities commissioning and qualification and ongoing work activities of low to moderate complexity, individually and with support of others. The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit. The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short term projects according to established policies and procedures. Required Competencies Knowledge, Skills, and Abilities: Intermediate knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment. Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing. REQUIRED: Intermediate knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems. PREFERRED: Commissioning and qualification of liquid nitrogen supply systems, DI Water, autoclaves, isolators, filling and capping equipment, and airflow visualization studies. Understanding of scheduling and execution fundamentals. Strong written and verbal communication skills. Excellent interpersonal skills with experience dealing with a diverse workforce. Strong multi tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. High proficiency in MS Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business. Working knowledge of scheduling software and systems, and inventory management systems. Ability to create and analyze meaningful metrics. DUTIES AND RESPONSIBILITIES 1) Commissioning and Qualification: a. Administer change control activities and corrective and preventive actions. b. Review, approve, and execute test protocols, validation deliverables, and plans as needed. c. Author, review, and approve SOPs, work practices, and other procedural documents. d. Provide input and guidance for change strategy, risk assessment, testing and compliance gaps. e. Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable. 2) Promotes and provides excellent customer service and support: a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests. b. Provides technical support and guidance on equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met. c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment. 3) Communication and Management of Timelines: a. Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel. b. Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders. c. Continually seeks opportunities to increase internal client satisfaction and deepen client relationships. 4) Regulatory Responsibilities: a. Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other client standards and regulations. b. Acts as equipment commissioning and qualification SME in internal and regulatory audits. 4. EDUCATION AND EXPERIENCE: BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs. Minimum of 3 years of experience in FDA-regulated industry. Minimum of 3 years of experience developing and execution facility and utility qualification. Strong background and experience in laboratory and manufacturing operations. Knowledge of cGMP in the pharmaceutical industry. Thorough knowledge and hands-on experience in commissioning and qualification of manufacturing facilities: REQUIRED - manufacturing rooms, material path-throughs; Thorough knowledge and hands-on experience in commissioning and qualification of common utilities: REQUIRED - compressed air, carbon dioxide, process air, AHUs; PREFERRED - liquid nitrogen supply systems, DI Water. Thorough knowledge and hands-on experience with airflow visualization (smoke studies). Strong computer skills, knowledge of calibration management and environmental monitoring systems preferred. Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently. Experience interacting with external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions is preferred. Strong interpersonal and communication skills, a team player willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
03/28/2024
Full time
Title- Equipment Commissioning Specialist Duration- 12+ months Location- Warren, NJ Pay range- $50 to $53.00/hr This role supports the successful operation of facilities, laboratories, and business functions at multi use sites through interaction with internal team members and peer level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Facilities and Utilities commissioning and qualification and ongoing work activities of low to moderate complexity, individually and with support of others. The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit. The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short term projects according to established policies and procedures. Required Competencies Knowledge, Skills, and Abilities: Intermediate knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment. Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing. REQUIRED: Intermediate knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems. PREFERRED: Commissioning and qualification of liquid nitrogen supply systems, DI Water, autoclaves, isolators, filling and capping equipment, and airflow visualization studies. Understanding of scheduling and execution fundamentals. Strong written and verbal communication skills. Excellent interpersonal skills with experience dealing with a diverse workforce. Strong multi tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. High proficiency in MS Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business. Working knowledge of scheduling software and systems, and inventory management systems. Ability to create and analyze meaningful metrics. DUTIES AND RESPONSIBILITIES 1) Commissioning and Qualification: a. Administer change control activities and corrective and preventive actions. b. Review, approve, and execute test protocols, validation deliverables, and plans as needed. c. Author, review, and approve SOPs, work practices, and other procedural documents. d. Provide input and guidance for change strategy, risk assessment, testing and compliance gaps. e. Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable. 2) Promotes and provides excellent customer service and support: a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests. b. Provides technical support and guidance on equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met. c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment. 3) Communication and Management of Timelines: a. Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel. b. Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders. c. Continually seeks opportunities to increase internal client satisfaction and deepen client relationships. 4) Regulatory Responsibilities: a. Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other client standards and regulations. b. Acts as equipment commissioning and qualification SME in internal and regulatory audits. 4. EDUCATION AND EXPERIENCE: BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs. Minimum of 3 years of experience in FDA-regulated industry. Minimum of 3 years of experience developing and execution facility and utility qualification. Strong background and experience in laboratory and manufacturing operations. Knowledge of cGMP in the pharmaceutical industry. Thorough knowledge and hands-on experience in commissioning and qualification of manufacturing facilities: REQUIRED - manufacturing rooms, material path-throughs; Thorough knowledge and hands-on experience in commissioning and qualification of common utilities: REQUIRED - compressed air, carbon dioxide, process air, AHUs; PREFERRED - liquid nitrogen supply systems, DI Water. Thorough knowledge and hands-on experience with airflow visualization (smoke studies). Strong computer skills, knowledge of calibration management and environmental monitoring systems preferred. Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently. Experience interacting with external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions is preferred. Strong interpersonal and communication skills, a team player willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Overview Weatherford is a leading global energy services company. Our world-class experts partner with customers to optimize their resources and realize the full potential of their assets. Across our operating locations, including manufacturing, research and development, service, and training facilities, operators choose us for strategic solutions that add efficiency, flexibility, and responsibility to any energy operation. We are focused on technology development, digital solutions, and defining our footprint in the new energy space. Our ability to provide integrated solutions across our segments will be critical to growth in our core operations and the energy transition. Energy producers face unique challenges every day, so it is our job to create solutions that enhance safety, streamline operations, and sustain uptime to meet or exceed their targets. We operate across the global energy landscape employing some of the best diverse talent in the industry. At Weatherford, we understand the value each individual brings to the table. We celebrate diversity in all its forms and are immensely proud of our workforce. We invite you to join our passionate, talented, world-class team. When you join Weatherford, you instantly feel connected to something bigger - a community that is grounded by our core values and driven to create innovative solutions for our customers. We celebrate each other's successes, grow together, and learn from each other constantly. Individually, we are impressive. Together, we are unstoppable. We are One Weatherford. Weatherford offers competitive compensation, a comprehensive benefits program and provides you a challenging and enriching career path, with a healthy balance of structure and flexibility to chart your own course. Weatherford 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. Responsibilities To provide installation, repairs and routine servicing of Digital Solutions in the shop and in the field. Help generate business to increase revenues through sales of Weatherford products and services. This is the senior level job for Field Specialist, who have a demanding, hands-on job that makes use of the latest technologies to deliver solutions for our clients. Acts to manage field crews whenever necessary (similar to engineers) but also with a great deal of autonomy and responsibility. They are trained and certified to maintain and run Special Services operations, among others. Independently applies extensive and diversified knowledge of principles and practices in broad areas of assignments and related fields. Uses advanced techniques in the modification or extension of theories and practices to complete assignments. Works on a major project or several projects of moderate scope with complex features. Reviews project documents for conformity and quality assurance. Develops new techniques and or improved processes or materials, or products. Acts as technical specialist or advisor to management and staff. Oversees junior level specialists in completion of their assignments. Receives supervision and guidance relating to overall objectives and critical issues, new concepts and policy matters. Responsibilities and duties: Responsible for installation, commissioning, and servicing of Company's specialty VFD products, Rod Pump Controllers and general oilfield electrical equipment. Able to work alone, in remote locations with little to no supervision or assistance. Availability to work the hours required to complete projects on time, including daily overtime, Weekends and Holiday. Support company products by building customer relationships and support products via phone, text, or in person. Promote the merits of our Products and Company to customers with the intent of problem solving and generating solutions. Know and understand Weatherford Quality Policy and comply with all requirements of the Quality Systems Manual, Operating and Technical Procedures and Workplace Instructions. P rovide on-site training for Customer field personal and Weatherford employees. Promote and maintain safe work practices through training and inspection through OSHA, NFPA70E, Weatherford training, and customer site specific rules or orientation. Able to provide team leadership in different environments when mentoring, working with other departments/projects, problem solving and ensuring product applications meet customer expectations. Know and understand Weatherford's Quality Policy and comply with all requirements of the Quality Systems Manual, Operating and Technical. Representative as a field contact for the customer. Maintain a professional appearance and attitude through all interactions. Qualifications Knowledge and operation of a multi-meter for voltage, current and resistance measurement. Understanding of interface devices, both analog and digital for monitoring and controls. Diagnose and trouble shoot electro/pneumatic systems. Understand wireless communication, design and interfacing with pre-existing network infrastructure. Must use computer proficiency to interface and configure a wide variety of third party electronic devices. Able to perform various other duties and activities as assigned by supervisor within the physical constraints of the job. Proficient in Mircrosoft Office applications including Outlook, Excel, Word, and Powerpoint) Able to drive/travel while following Weatherford Policy and requirements. Requires 70% travel.
03/02/2024
Full time
Overview Weatherford is a leading global energy services company. Our world-class experts partner with customers to optimize their resources and realize the full potential of their assets. Across our operating locations, including manufacturing, research and development, service, and training facilities, operators choose us for strategic solutions that add efficiency, flexibility, and responsibility to any energy operation. We are focused on technology development, digital solutions, and defining our footprint in the new energy space. Our ability to provide integrated solutions across our segments will be critical to growth in our core operations and the energy transition. Energy producers face unique challenges every day, so it is our job to create solutions that enhance safety, streamline operations, and sustain uptime to meet or exceed their targets. We operate across the global energy landscape employing some of the best diverse talent in the industry. At Weatherford, we understand the value each individual brings to the table. We celebrate diversity in all its forms and are immensely proud of our workforce. We invite you to join our passionate, talented, world-class team. When you join Weatherford, you instantly feel connected to something bigger - a community that is grounded by our core values and driven to create innovative solutions for our customers. We celebrate each other's successes, grow together, and learn from each other constantly. Individually, we are impressive. Together, we are unstoppable. We are One Weatherford. Weatherford offers competitive compensation, a comprehensive benefits program and provides you a challenging and enriching career path, with a healthy balance of structure and flexibility to chart your own course. Weatherford 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. Responsibilities To provide installation, repairs and routine servicing of Digital Solutions in the shop and in the field. Help generate business to increase revenues through sales of Weatherford products and services. This is the senior level job for Field Specialist, who have a demanding, hands-on job that makes use of the latest technologies to deliver solutions for our clients. Acts to manage field crews whenever necessary (similar to engineers) but also with a great deal of autonomy and responsibility. They are trained and certified to maintain and run Special Services operations, among others. Independently applies extensive and diversified knowledge of principles and practices in broad areas of assignments and related fields. Uses advanced techniques in the modification or extension of theories and practices to complete assignments. Works on a major project or several projects of moderate scope with complex features. Reviews project documents for conformity and quality assurance. Develops new techniques and or improved processes or materials, or products. Acts as technical specialist or advisor to management and staff. Oversees junior level specialists in completion of their assignments. Receives supervision and guidance relating to overall objectives and critical issues, new concepts and policy matters. Responsibilities and duties: Responsible for installation, commissioning, and servicing of Company's specialty VFD products, Rod Pump Controllers and general oilfield electrical equipment. Able to work alone, in remote locations with little to no supervision or assistance. Availability to work the hours required to complete projects on time, including daily overtime, Weekends and Holiday. Support company products by building customer relationships and support products via phone, text, or in person. Promote the merits of our Products and Company to customers with the intent of problem solving and generating solutions. Know and understand Weatherford Quality Policy and comply with all requirements of the Quality Systems Manual, Operating and Technical Procedures and Workplace Instructions. P rovide on-site training for Customer field personal and Weatherford employees. Promote and maintain safe work practices through training and inspection through OSHA, NFPA70E, Weatherford training, and customer site specific rules or orientation. Able to provide team leadership in different environments when mentoring, working with other departments/projects, problem solving and ensuring product applications meet customer expectations. Know and understand Weatherford's Quality Policy and comply with all requirements of the Quality Systems Manual, Operating and Technical. Representative as a field contact for the customer. Maintain a professional appearance and attitude through all interactions. Qualifications Knowledge and operation of a multi-meter for voltage, current and resistance measurement. Understanding of interface devices, both analog and digital for monitoring and controls. Diagnose and trouble shoot electro/pneumatic systems. Understand wireless communication, design and interfacing with pre-existing network infrastructure. Must use computer proficiency to interface and configure a wide variety of third party electronic devices. Able to perform various other duties and activities as assigned by supervisor within the physical constraints of the job. Proficient in Mircrosoft Office applications including Outlook, Excel, Word, and Powerpoint) Able to drive/travel while following Weatherford Policy and requirements. Requires 70% travel.
Donnelley Financial Solutions
Palo Alto, California
Description: Donnelley Financial Solutions (DFIN) is a leader in risk and compliance solutions, providing insightful technology, industry expertise and data insights to clients across the globe. We're here to help you make smarter decisions with insightful technology, industry expertise and data insights at every stage of your business and investment lifecycles. As markets fluctuate, regulations evolve and technology advances, we're there. And through it all, we deliver confidence with the right solutions in moments that matter. Summary: Acts as a project manager and service liaison between customer, sales, and multiple production platforms. Advocates on behalf of the client with a proactive, collaborative approach to all departments and the production team. Uses experience and knowledge, including that of XBRL, to provide advisory and consultant services to clients to provide direction in meeting their project needs and goals to achieve and meet all regulatory requirements of the client. Works directly with clients to develops an overall plan to coordinate the production of client documents, electronic SEC filings and print production in order to achieve the objectives of the service agreement in compliance of customer expectations, company policy, and profit and quality requirements. Applies understanding of customer's business needs in building solid customer relationships, monitoring customer satisfaction, and providing consulting in conjunction with sales. May participate in support roles in sales presentations and client site visits with sales force. May serve in leadership roles within shifts or project teams to lead successful accomplishment of the above objectives. Has primary responsibility for all steps of service delivery, including Composition and Manufacturing through final disposition of the customer product. Responsibilities: Work assignments are often routine but on occasion may be non-routine and require some deviation from accepted practice and procedures to complete. Assignments are given in terms of subject area concerned, with specific objectives and possible problems identified. Follow guidelines which may include company and/or departmental policies and procedures, and rules and regulations that are well established but may require some deviation from normal operating procedures when completing more unique assignments. Engage customers to gather job requirements and translate customer requirements into detailed workflow instructions and oversee workflow across multiple departments such as Composition, Desktop, Prepress, Manufacturing & Shipping. Engage clients in Filing, Print, Word Processing and XBRL to provide them with the best possible experience. Responsible for researching and compiling all required data elements needed to prepare the appropriate electronic filing and/or composition of SEC EDGAR filings, prospectuses, annual reports and other financial compliance documents. Provide quality review for other Account Specialists to ensure all information is accounted for and accurate before commencement of composition, print orders or filing of online EDGAR filings. Confer with customers and/or customers legal counsel throughout Composition to keep them informed of the status of jobs, solicit additional information needed for current jobs and coordinate changes to jobs. Ensure final documents are signed off and approved for print or positing to online systems. Additional Responsibilities: May coordinate production of printed documents and components with other internal plants and/or external vendors. Engage appropriate departments to verify the issue and determine the root cause on issues that arise. Communicate with customers regarding the resolution of issues. Monitor progress of jobs throughout production, conferring with manufacturing operations on counts and final runs and ensure the final product meets customer requirements and company standards. May tally the final production runs and work performed to assemble paperwork for billing purposes. Maintain continuing education and training in new Financial Services platforms and technologies as they are implemented and introduced into the service offerings. Mentor and train Account specialist 1 and 2 levels. Management and coordination of projects for new and existing clients including managing the client experience and interaction with other team members. May present internal and client presentations regarding Financial Services products and offerings relevant to specific client needs. Performs other related duties and participates in special projects as assigned. Basic Qualifications: The qualifications below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor degree in discipline related to functional work or role with 5-7 years of relevant work experience managing all Financial Services products, including Printed Documents and SEC. A degree in Accounting/Finance, or accountancy experience, would be a strong positive. Filings OR demonstrated ability to meet the job requirements through a comparable number of years of applicable work experience. Preferred Qualifications: Able to apply broad work experience and knowledge when analyzing complex problems. Must be able consistently identify critical elements, variables and alternatives to develop solutions. Must be able to organize/prioritize existing resources and incorporate new information, as needed, to implement the most effective solutions. Able to communicate clearly and courteously with those who need to know of decisions/actions/problems. Able to apply excellent business acumen and collaborative skills when resolving problems. Able to apply excellent functional computer knowledge in utilizing Microsoft Windows, or other technical tools in completing assignments. Able to apply expertise in all the tools or applications used to complete work assignments. Able to mentor junior level team members in the use of tools and/or systems in the position. Requires excellent communication skills with ability to state messages in a clear manner by using language that is easy for others to understand. Able to explain programs policies and procedures in language that is understood by others. Must be able to modify communication style both formal and informal to match the appropriate level of the audience targeted. Requires strong understanding of the impact of a message on the organization or customer. Able to write with the clarity and precision necessary for the work being performed. It is the policy of Donnelley Financial Solutions to select, place and manage all its employees without discrimination based on race, color, national origin, gender, age, religion, actual or perceived disability, veteran's status, actual or perceived sexual orientation, genetic information or any other protected status. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access jobs.dfinsolutions.com as a result of your disability. You can request a reasonable accommodation by sending an email to .#BI-Remote
11/05/2021
Full time
Description: Donnelley Financial Solutions (DFIN) is a leader in risk and compliance solutions, providing insightful technology, industry expertise and data insights to clients across the globe. We're here to help you make smarter decisions with insightful technology, industry expertise and data insights at every stage of your business and investment lifecycles. As markets fluctuate, regulations evolve and technology advances, we're there. And through it all, we deliver confidence with the right solutions in moments that matter. Summary: Acts as a project manager and service liaison between customer, sales, and multiple production platforms. Advocates on behalf of the client with a proactive, collaborative approach to all departments and the production team. Uses experience and knowledge, including that of XBRL, to provide advisory and consultant services to clients to provide direction in meeting their project needs and goals to achieve and meet all regulatory requirements of the client. Works directly with clients to develops an overall plan to coordinate the production of client documents, electronic SEC filings and print production in order to achieve the objectives of the service agreement in compliance of customer expectations, company policy, and profit and quality requirements. Applies understanding of customer's business needs in building solid customer relationships, monitoring customer satisfaction, and providing consulting in conjunction with sales. May participate in support roles in sales presentations and client site visits with sales force. May serve in leadership roles within shifts or project teams to lead successful accomplishment of the above objectives. Has primary responsibility for all steps of service delivery, including Composition and Manufacturing through final disposition of the customer product. Responsibilities: Work assignments are often routine but on occasion may be non-routine and require some deviation from accepted practice and procedures to complete. Assignments are given in terms of subject area concerned, with specific objectives and possible problems identified. Follow guidelines which may include company and/or departmental policies and procedures, and rules and regulations that are well established but may require some deviation from normal operating procedures when completing more unique assignments. Engage customers to gather job requirements and translate customer requirements into detailed workflow instructions and oversee workflow across multiple departments such as Composition, Desktop, Prepress, Manufacturing & Shipping. Engage clients in Filing, Print, Word Processing and XBRL to provide them with the best possible experience. Responsible for researching and compiling all required data elements needed to prepare the appropriate electronic filing and/or composition of SEC EDGAR filings, prospectuses, annual reports and other financial compliance documents. Provide quality review for other Account Specialists to ensure all information is accounted for and accurate before commencement of composition, print orders or filing of online EDGAR filings. Confer with customers and/or customers legal counsel throughout Composition to keep them informed of the status of jobs, solicit additional information needed for current jobs and coordinate changes to jobs. Ensure final documents are signed off and approved for print or positing to online systems. Additional Responsibilities: May coordinate production of printed documents and components with other internal plants and/or external vendors. Engage appropriate departments to verify the issue and determine the root cause on issues that arise. Communicate with customers regarding the resolution of issues. Monitor progress of jobs throughout production, conferring with manufacturing operations on counts and final runs and ensure the final product meets customer requirements and company standards. May tally the final production runs and work performed to assemble paperwork for billing purposes. Maintain continuing education and training in new Financial Services platforms and technologies as they are implemented and introduced into the service offerings. Mentor and train Account specialist 1 and 2 levels. Management and coordination of projects for new and existing clients including managing the client experience and interaction with other team members. May present internal and client presentations regarding Financial Services products and offerings relevant to specific client needs. Performs other related duties and participates in special projects as assigned. Basic Qualifications: The qualifications below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor degree in discipline related to functional work or role with 5-7 years of relevant work experience managing all Financial Services products, including Printed Documents and SEC. A degree in Accounting/Finance, or accountancy experience, would be a strong positive. Filings OR demonstrated ability to meet the job requirements through a comparable number of years of applicable work experience. Preferred Qualifications: Able to apply broad work experience and knowledge when analyzing complex problems. Must be able consistently identify critical elements, variables and alternatives to develop solutions. Must be able to organize/prioritize existing resources and incorporate new information, as needed, to implement the most effective solutions. Able to communicate clearly and courteously with those who need to know of decisions/actions/problems. Able to apply excellent business acumen and collaborative skills when resolving problems. Able to apply excellent functional computer knowledge in utilizing Microsoft Windows, or other technical tools in completing assignments. Able to apply expertise in all the tools or applications used to complete work assignments. Able to mentor junior level team members in the use of tools and/or systems in the position. Requires excellent communication skills with ability to state messages in a clear manner by using language that is easy for others to understand. Able to explain programs policies and procedures in language that is understood by others. Must be able to modify communication style both formal and informal to match the appropriate level of the audience targeted. Requires strong understanding of the impact of a message on the organization or customer. Able to write with the clarity and precision necessary for the work being performed. It is the policy of Donnelley Financial Solutions to select, place and manage all its employees without discrimination based on race, color, national origin, gender, age, religion, actual or perceived disability, veteran's status, actual or perceived sexual orientation, genetic information or any other protected status. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access jobs.dfinsolutions.com as a result of your disability. You can request a reasonable accommodation by sending an email to .#BI-Remote
NO SPONSORSHIP Lead Cybersecurity Applications Security Looking for a candidate with Applications Security, penetration testing, Cloud, DevOps, Python, JAVA, C# etc traditional applications vulnerability management working with applications Job Summary The Principal Cybersecurity Application Security Specialist is recognized across the organization for functional expertise in application security and penetration testing. The Principal Cybersecurity Application Security Specialist will be required to effectively translate business objectives and risk management strategies into specific security technologies and services and will serve as an expert resource for those technologies. Responsibilities Serve as the Subject Matter Expert for a collection of critical cybersecurity technologies, possessing the highest level of expertise in the design, deployment, maintenance and remediation of those technologies Expert level of proficiency with application security scanning tools and foundational concepts of secure development principles Expert level of penetration testing skill against cloud applications, traditional applications and infrastructure Provides a clear technical capability roadmap for cybersecurity tools for which you are responsible, in coordination with Security Architecture Coordinate with Cybersecurity leadership and business owners to determine business needs and requirements Track developments and changes in the digital business and threat environments to ensure that they're adequately addressed in security strategy plans and architecture artifacts Validate IT infrastructure, applications and other reference architectures for security best practices and recommend changes to enhance security and reduce risks, where applicable Review security technologies, tools and services, and make recommendations to the broader security team for their use, based on security, financial and operational metrics Liaise with other practitioners across the Digital organization to share best practices and insights Mentor and grow junior level associates Qualifications Bachelor's Degree A minimum of 7 years related work experience Certified Information Systems Security Professional (CISSP), Certified Ethical Hacker (CEH) or Certified The Principal Cybersecurity Application Security Specialist should have a minimum of 5-7 years of direct, documented, and verifiable experience with the following: Strong communication and presentation skills Experience with deploying enterprise-wide, complex technology projects Experience and strong working knowledge of managing security infrastructure (eg, Firewalls, intrusion prevention systems (IPSs), web application Firewalls (WAFs), endpoint protection, SIEM, and log management technology) Experience and strong working knowledge of vulnerability management tools Experience and a strong working knowledge of the methodologies to conduct risk assessment exercises on new applications and services Full-stack knowledge of IT infrastructure: Applications Databases Operating systems - Windows and Linux Hypervisors Networks - WAN, LAN, SCADA, Storage and Backup Direct experience designing IAM technologies and services: Active Directory Lightweight Directory Access Protocol (LDAP) Amazon Web Service (AWS) IAM Experience leading the deployment of applications and infrastructure into public cloud services
09/09/2021
Full time
NO SPONSORSHIP Lead Cybersecurity Applications Security Looking for a candidate with Applications Security, penetration testing, Cloud, DevOps, Python, JAVA, C# etc traditional applications vulnerability management working with applications Job Summary The Principal Cybersecurity Application Security Specialist is recognized across the organization for functional expertise in application security and penetration testing. The Principal Cybersecurity Application Security Specialist will be required to effectively translate business objectives and risk management strategies into specific security technologies and services and will serve as an expert resource for those technologies. Responsibilities Serve as the Subject Matter Expert for a collection of critical cybersecurity technologies, possessing the highest level of expertise in the design, deployment, maintenance and remediation of those technologies Expert level of proficiency with application security scanning tools and foundational concepts of secure development principles Expert level of penetration testing skill against cloud applications, traditional applications and infrastructure Provides a clear technical capability roadmap for cybersecurity tools for which you are responsible, in coordination with Security Architecture Coordinate with Cybersecurity leadership and business owners to determine business needs and requirements Track developments and changes in the digital business and threat environments to ensure that they're adequately addressed in security strategy plans and architecture artifacts Validate IT infrastructure, applications and other reference architectures for security best practices and recommend changes to enhance security and reduce risks, where applicable Review security technologies, tools and services, and make recommendations to the broader security team for their use, based on security, financial and operational metrics Liaise with other practitioners across the Digital organization to share best practices and insights Mentor and grow junior level associates Qualifications Bachelor's Degree A minimum of 7 years related work experience Certified Information Systems Security Professional (CISSP), Certified Ethical Hacker (CEH) or Certified The Principal Cybersecurity Application Security Specialist should have a minimum of 5-7 years of direct, documented, and verifiable experience with the following: Strong communication and presentation skills Experience with deploying enterprise-wide, complex technology projects Experience and strong working knowledge of managing security infrastructure (eg, Firewalls, intrusion prevention systems (IPSs), web application Firewalls (WAFs), endpoint protection, SIEM, and log management technology) Experience and strong working knowledge of vulnerability management tools Experience and a strong working knowledge of the methodologies to conduct risk assessment exercises on new applications and services Full-stack knowledge of IT infrastructure: Applications Databases Operating systems - Windows and Linux Hypervisors Networks - WAN, LAN, SCADA, Storage and Backup Direct experience designing IAM technologies and services: Active Directory Lightweight Directory Access Protocol (LDAP) Amazon Web Service (AWS) IAM Experience leading the deployment of applications and infrastructure into public cloud services
For over 230 years, Bank of New York Mellon (BNY Mellon) has been at the center of the global financial markets, providing the world's leading institutions the tools, capabilities, and services to be distinctive investors. BNY Mellon has approximately $15 billion in revenues and market capitalization of approximately $50 billion. BNY Mellon is a leader in the world of investment services and investment management, and our businesses support the full range of stakeholders of the financial system including: Managing the custody of over $31 trillion financial assets of the world's leading institutional investors, hedge funds, sovereign wealth funds, and corporates Investing over $1.8 trillion as one of the largest global asset managers across a wide range of asset classes Providing collateral, liquidity, and funding for the world's largest banks through our markets franchise Serving family offices and high net worth individuals in our top 10 wealth manager ($250 billion assets) Providing a full suite of solutions to advisors, broker-dealers, family offices, hedge and '40 Act fund managers, registered investment advisor firms and wealth managers (over $1.8 trillion in client assets) Advising large global corporations on a range of trust and other solutions Providing integrated managed data services to asset managers (over $4.7 trillion) Leads product management, development and strategy for large and/or complex products. Usually assigned to product areas with high-growth potential and has fully developed core expertise on industry trends, market segments and competitor services/offerings. Develops ideas for new products. Ensures that risk, regulations, and market conditions are accounted for throughout the life-cycle of developed products. Analyzes complex client requirements and develops solutions that may include more than one product. Must understand the economics behind products and demonstrate business acumen. Independently manages the development, enhancement, and profitability of assigned products and performs both operational and marketing analysis to ensure profitability and penetration goals are met. Manages relationship with Operations, Technology, Risk, Compliance, Legal, etc. to ensure different requirements are met during the new product development, enhancement, delivery, strategy, and planning processes. Employs a client-focused, strategic approach to develop the business case for firm offerings in the marketplace through in-depth and complex analyses on client segments, competitive landscape and industry environment. Demonstrates in-depth and comprehensive knowledge of assigned products, the marketplace and client needs to drive product growth/development and maximize profitability. Creates product management roadmaps and establishes evaluation criteria and success metrics. Leads pricing, promotion, distribution strategies and competitive differentiators. Positions products for specific client segments, highlighting key benefits and competitive advantages. Engages with Sales and relationship Management in supporting business sales. Performs technical training, demonstration and develops user guides for clients while also preparing sales materials and training BNY Mellon professionals. Guides junior product managers and directs and works with operations and systems managers during product implementation to ensure operating plan goals are met. No direct reports. Provides guidance to less experienced colleagues as needed. May lead others on project teams. Contributes to the achievement of area objectives and profitability of assigned product(s). Qualifications Bachelor's degree or the equivalent combination of education and experience is required. Advanced/graduate degree preferred. MBA or CFA preferred. 7-10 years of total work experience preferred. Cash Management background is strongly preferred Experience in Product Management, operations, client management preferred. Product Leadership Certification preferred. BNY Mellon is an Equal Employment Opportunity/Affirmative Action Employer. Minorities/Females/Individuals With Disabilities/Protected Veterans. Our ambition is to build the best global team - one that is representative and inclusive of the diverse talent, clients and communities we work with and serve - and to empower our team to do their best work. We support wellbeing and a balanced life, and offer a range of family-friendly, inclusive employment policies and employee forums. Primary Location: United States-New York-New York Internal Jobcode: 70237 Job: General Mgmt / Admin Organization: Global Product Management-HR07027 Requisition Number:
01/31/2021
Full time
For over 230 years, Bank of New York Mellon (BNY Mellon) has been at the center of the global financial markets, providing the world's leading institutions the tools, capabilities, and services to be distinctive investors. BNY Mellon has approximately $15 billion in revenues and market capitalization of approximately $50 billion. BNY Mellon is a leader in the world of investment services and investment management, and our businesses support the full range of stakeholders of the financial system including: Managing the custody of over $31 trillion financial assets of the world's leading institutional investors, hedge funds, sovereign wealth funds, and corporates Investing over $1.8 trillion as one of the largest global asset managers across a wide range of asset classes Providing collateral, liquidity, and funding for the world's largest banks through our markets franchise Serving family offices and high net worth individuals in our top 10 wealth manager ($250 billion assets) Providing a full suite of solutions to advisors, broker-dealers, family offices, hedge and '40 Act fund managers, registered investment advisor firms and wealth managers (over $1.8 trillion in client assets) Advising large global corporations on a range of trust and other solutions Providing integrated managed data services to asset managers (over $4.7 trillion) Leads product management, development and strategy for large and/or complex products. Usually assigned to product areas with high-growth potential and has fully developed core expertise on industry trends, market segments and competitor services/offerings. Develops ideas for new products. Ensures that risk, regulations, and market conditions are accounted for throughout the life-cycle of developed products. Analyzes complex client requirements and develops solutions that may include more than one product. Must understand the economics behind products and demonstrate business acumen. Independently manages the development, enhancement, and profitability of assigned products and performs both operational and marketing analysis to ensure profitability and penetration goals are met. Manages relationship with Operations, Technology, Risk, Compliance, Legal, etc. to ensure different requirements are met during the new product development, enhancement, delivery, strategy, and planning processes. Employs a client-focused, strategic approach to develop the business case for firm offerings in the marketplace through in-depth and complex analyses on client segments, competitive landscape and industry environment. Demonstrates in-depth and comprehensive knowledge of assigned products, the marketplace and client needs to drive product growth/development and maximize profitability. Creates product management roadmaps and establishes evaluation criteria and success metrics. Leads pricing, promotion, distribution strategies and competitive differentiators. Positions products for specific client segments, highlighting key benefits and competitive advantages. Engages with Sales and relationship Management in supporting business sales. Performs technical training, demonstration and develops user guides for clients while also preparing sales materials and training BNY Mellon professionals. Guides junior product managers and directs and works with operations and systems managers during product implementation to ensure operating plan goals are met. No direct reports. Provides guidance to less experienced colleagues as needed. May lead others on project teams. Contributes to the achievement of area objectives and profitability of assigned product(s). Qualifications Bachelor's degree or the equivalent combination of education and experience is required. Advanced/graduate degree preferred. MBA or CFA preferred. 7-10 years of total work experience preferred. Cash Management background is strongly preferred Experience in Product Management, operations, client management preferred. Product Leadership Certification preferred. BNY Mellon is an Equal Employment Opportunity/Affirmative Action Employer. Minorities/Females/Individuals With Disabilities/Protected Veterans. Our ambition is to build the best global team - one that is representative and inclusive of the diverse talent, clients and communities we work with and serve - and to empower our team to do their best work. We support wellbeing and a balanced life, and offer a range of family-friendly, inclusive employment policies and employee forums. Primary Location: United States-New York-New York Internal Jobcode: 70237 Job: General Mgmt / Admin Organization: Global Product Management-HR07027 Requisition Number:
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit assignments and critical actions. Reviews all materials and batch records required to support shift and any off shift needs for the day. Provides on the floor training to support formalized technical and GMP training. Check that operator training files match and support the processes they are required to carry out. Monitors operator training files and work with compliance specialist to keep files up to date. Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs. Works with technology transfer team to incorporate new processes in the plant. Works interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communications at all levels. Ensures that direct materials budgets and overtime budgets are met. Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel. Evaluates staff performance. Qualifications Requires a Bachelor's degree or equivalent; Six to eight plus years' experience in all aspects of manufacturing/ production processes Computer proficiency and scheduling experience required; good writing skills. Working knowledge of safety, quality systems, and cGMPs is required Familiarity with industrial automation (e.g., distributed control and PLC-based systems Familiarity with equipment and facilities validation Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/26/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit assignments and critical actions. Reviews all materials and batch records required to support shift and any off shift needs for the day. Provides on the floor training to support formalized technical and GMP training. Check that operator training files match and support the processes they are required to carry out. Monitors operator training files and work with compliance specialist to keep files up to date. Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs. Works with technology transfer team to incorporate new processes in the plant. Works interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communications at all levels. Ensures that direct materials budgets and overtime budgets are met. Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel. Evaluates staff performance. Qualifications Requires a Bachelor's degree or equivalent; Six to eight plus years' experience in all aspects of manufacturing/ production processes Computer proficiency and scheduling experience required; good writing skills. Working knowledge of safety, quality systems, and cGMPs is required Familiarity with industrial automation (e.g., distributed control and PLC-based systems Familiarity with equipment and facilities validation Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Regeneron Pharmaceuticals, Inc.
Rensselaer, New York
We are currently looking to fill a Quality Assurance Specialist (Filling) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: • Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution • Representing the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communications • Training and/or mentoring junior employees, including providing insights and education on processes and procedures • Providing consultation or advice in alignment with QA policies • Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk • Reviewing, editing, or approving Regeneron controlled documents • Participating in investigations associated with raw materials or product • Performing status labeling of raw materials and product • Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement This role may be for you if you: • Excel in a quality driven organization • Have an understanding of biologics manufacturing operations • Are organized and have an attention to detail • Can prioritize multiple assignments and changing priorities • Are able to learn and utilize computerized systems for daily performance of tasks To be considered for this role you must hold a Bachelor's degree 0-2+ years of relevant experience for QA Associate level, 2+ years for Associate Specialist level, 4+ years for Specialist level, 6+ years for Senior level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-DF1
01/25/2021
Full time
We are currently looking to fill a Quality Assurance Specialist (Filling) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: • Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution • Representing the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communications • Training and/or mentoring junior employees, including providing insights and education on processes and procedures • Providing consultation or advice in alignment with QA policies • Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk • Reviewing, editing, or approving Regeneron controlled documents • Participating in investigations associated with raw materials or product • Performing status labeling of raw materials and product • Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement This role may be for you if you: • Excel in a quality driven organization • Have an understanding of biologics manufacturing operations • Are organized and have an attention to detail • Can prioritize multiple assignments and changing priorities • Are able to learn and utilize computerized systems for daily performance of tasks To be considered for this role you must hold a Bachelor's degree 0-2+ years of relevant experience for QA Associate level, 2+ years for Associate Specialist level, 4+ years for Specialist level, 6+ years for Senior level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-DF1
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit assignments and critical actions. Reviews all materials and batch records required to support shift and any off shift needs for the day. Provides on the floor training to support formalized technical and GMP training. Check that operator training files match and support the processes they are required to carry out. Monitors operator training files and work with compliance specialist to keep files up to date. Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs. Works with technology transfer team to incorporate new processes in the plant. Works interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communications at all levels. Ensures that direct materials budgets and overtime budgets are met. Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel. Evaluates staff performance. Qualifications Requires a Bachelor's degree or equivalent; Eight plus years' experience in all aspects of manufacturing/ production processes Computer proficiency and scheduling experience required; good writing skills. Working knowledge of safety, quality systems, and cGMPs is required Familiarity with industrial automation (e.g., distributed control and PLC-based systems Familiarity with equipment and facilities validation Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/19/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit assignments and critical actions. Reviews all materials and batch records required to support shift and any off shift needs for the day. Provides on the floor training to support formalized technical and GMP training. Check that operator training files match and support the processes they are required to carry out. Monitors operator training files and work with compliance specialist to keep files up to date. Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs. Works with technology transfer team to incorporate new processes in the plant. Works interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communications at all levels. Ensures that direct materials budgets and overtime budgets are met. Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel. Evaluates staff performance. Qualifications Requires a Bachelor's degree or equivalent; Eight plus years' experience in all aspects of manufacturing/ production processes Computer proficiency and scheduling experience required; good writing skills. Working knowledge of safety, quality systems, and cGMPs is required Familiarity with industrial automation (e.g., distributed control and PLC-based systems Familiarity with equipment and facilities validation Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Regeneron Pharmaceuticals, Inc.
Rensselaer, New York
Summary As a subject matter expert and leader in the laboratory, support the Manufacturing, Process Sciences (PS) and Quality Control (QC) departments through the development, optimization, troubleshooting, validation, transfer and application of analytical test procedures for product potency. The ideal candidate will lead a small team of Specialists and Scientists. Essential Duties and Responsibilities may include, but are not limited to, the following • Establish, develop, and/or optimize analytical methodology to test potency of protein products utilizing binding or cell-based assays in the QC laboratories. • Lead and develop a team of analysts in the implementation of potency assays • Stay informed in current industry trends in potency assay development and implementation in the QC environment • Design, write, and review protocols for assay qualification/validation studies. • Evaluate and make recommendations on new instrumentation and technology. • Transfer new or improved control test procedures to customer groups. • Lead troubleshooting activities for established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems. • Perform job duties with limited direction from supervisor. Design scientifically sound studies and experiments being given only a general outline of the study goal. • Tabulate results and write summary reports of assay development and validation studies. • Present findings at departmental and interdepartmental meetings. • Using the available scientific literature, develop scientific arguments for white paper justifications and investigation conclusions. • Produce and maintain accurate records. • Write group SOPs and provides drafts of proposed test methods to QC. • Train junior level group members and act as a mentor within the laboratory. • Represent Analytical Sciences on interdepartmental teams and in meetings Knowledge, Skills & Abilities • Ability to motivate employees and build team morale • Support employees, executing against established guidelines and common procedures and policies • Coordinate, organize and assign daily activities of operations • Ability to identify problems and escalate accordingly • Continuously drive to improve processes for improved performance • Ability to analyze and identify trends. • Develop and deliver effective presentations • Strong written communication • Ability to work in an ever-changing environment • Critical thinking skills Education and Experience • Requires PhD in Biology, Molecular Biology, Biochemistry, or Bioengineering with 3+ years of relevant experience; may consider another degree discipline; cGMP experience is strongly preferred • Previous supervisory experience preferred Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. -
09/30/2020
Full time
Summary As a subject matter expert and leader in the laboratory, support the Manufacturing, Process Sciences (PS) and Quality Control (QC) departments through the development, optimization, troubleshooting, validation, transfer and application of analytical test procedures for product potency. The ideal candidate will lead a small team of Specialists and Scientists. Essential Duties and Responsibilities may include, but are not limited to, the following • Establish, develop, and/or optimize analytical methodology to test potency of protein products utilizing binding or cell-based assays in the QC laboratories. • Lead and develop a team of analysts in the implementation of potency assays • Stay informed in current industry trends in potency assay development and implementation in the QC environment • Design, write, and review protocols for assay qualification/validation studies. • Evaluate and make recommendations on new instrumentation and technology. • Transfer new or improved control test procedures to customer groups. • Lead troubleshooting activities for established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems. • Perform job duties with limited direction from supervisor. Design scientifically sound studies and experiments being given only a general outline of the study goal. • Tabulate results and write summary reports of assay development and validation studies. • Present findings at departmental and interdepartmental meetings. • Using the available scientific literature, develop scientific arguments for white paper justifications and investigation conclusions. • Produce and maintain accurate records. • Write group SOPs and provides drafts of proposed test methods to QC. • Train junior level group members and act as a mentor within the laboratory. • Represent Analytical Sciences on interdepartmental teams and in meetings Knowledge, Skills & Abilities • Ability to motivate employees and build team morale • Support employees, executing against established guidelines and common procedures and policies • Coordinate, organize and assign daily activities of operations • Ability to identify problems and escalate accordingly • Continuously drive to improve processes for improved performance • Ability to analyze and identify trends. • Develop and deliver effective presentations • Strong written communication • Ability to work in an ever-changing environment • Critical thinking skills Education and Experience • Requires PhD in Biology, Molecular Biology, Biochemistry, or Bioengineering with 3+ years of relevant experience; may consider another degree discipline; cGMP experience is strongly preferred • Previous supervisory experience preferred Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. -