Manager Engineering Services Quality Management (ESQM)

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!

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat people with life-threatening medical conditions and to help them live full lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.

In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. In May 2020, CSL announced the strategic partnership with Thermo Fisher Scientific, the world leader in serving science. Thermo Fisher will lease and operate the Lengnau state-of-the-art biotech manufacturing facility once construction is completed in 2021. It is anticipated that employees at the site who are engaged for the operation of the site and the commercial production of our therapies in Lengnau will automatically transfer to Thermo Fisher Scientific once construction is complete. Today, more than 200 employees work in Lengnau.

You can find more information on the strategic partnership with Thermo Fisher here and some more information about the prospects of a future career with Thermo Fisher here .

We are looking for talented and dedicated personalities that share our passion to develop and deliver innovative therapies. With your commitment, reliability and high-quality standards you help us to improve the quality of life for those in need.

We are currently recruiting for a

Manager Engineering Services Quality Management (ESQM)

Position Purpose

• Supporting the Lengnau (LGN) Facility Project Team ambitions of delivering a 'Right First Time' project to manufacturing operations, the main responsibilities of this position are:
• Providing leadership in Engineering Quality Assurance matters
• Managing the Lengnau Facility Project Engineering Quality Management system to ensure Quality is proactively engineered into, and assured on the project by design engineers, vendors, contractors and constructors.
• Developing Project Quality Management plans, Audit processes and schedules and document review processes to assure the use of Good Engineering Practices and Good Documentation Practices and trains the project community in the same.
• Leads the Eng. QA team
• Strengthens collaboration with all project team functions and members
• Proactively identifies resource requirements and builds teams using both CSL and external resources.
• Member of the Facility Project Leadership team

Reporting Relationships:

The role reports to/dotted line reporting to Head of Facility Project

Key Interfaces

• Functional Heads of LGN Facility Project Team (CVQ, Quality and project managers other buildings)
• Construction Manager
• LGN PMO function

Main Responsibilities and Accountabilities

Technical Responsibilities

• Responsible for developing, receiving, approval for and maintaining the Project Quality Management System procedure, and Project Training Plan.
• Regular reporting of current performance of the PQMS to the Project Director
• Developing and maintaining the Audit Program and undertaking Quality and GDP audits as scheduled, conducting Internal CSL Quality Audits and External partner Quality Audits on Exyte, DPS, Construction Management, ANS, Vendors and subcontractors.
• Responsible for the leadership, performance and development of the Engineering Services Quality Management teams, incl. recruitment, supervision, engagement, coaching, development, evaluation...
• Responsible for establishing and facilitating a culture where Eng. QA practices are seen as key enablers for a successful project
• Ensure project documentation procedures and document deliverables are of an acceptable quality to support compliance to applicable standards. Approve relevant project procedures and documentation. Review and comment on general Project procedures to ensure control systems are in place with respect to activities affecting quality and documentation
• Ensure VTOPs are reviewed and turned over on time
• Engage with and support the various teams on the project (design, CM, CVQ, Safety etc.) for cross functional best practice sharing and issue resolution in regard to Compliance, Document Management and CVQ strategies and expertise.
• Developing Training Plans for Facility Project Team members in project procedures, Good Documentation Practice, Good Engineering Practices etc. Preparing training materials, providing and documenting training. Ensuring regular reporting of training status to Project Leadership

Leadership

• Maintains an external and strategic focus ensuring that his/her deliverables evolve to meet customers' and stakeholders' challenges and trends and that best practices from the outside environment and industry are incorporated and deployed
• Acts and promotes collaboration in the work environment and operates in full alignment with the company's core values
• Creates and promotes an accountable working environment by providing clear guidance and expectations to stakeholders and counterparts
• Ensures clarity and full understanding of the site/company's department strategy by promoting an effective and timely communication in the project team and towards all involved parties
• Promotes and executes a KPI drive management approach

• Degree in Engineering or Science preferable
• Strong operational experience gained in construction, commissioning and qualification environment preferably in Life Science/Pharma/Biotech/Fill Finish facility
• Proven experience and knowledge in process, automation and engineering relating to pharmaceutical of Biotech facilities
• Proven experience in GxP (GMP, GEP, GDP), qualification and validation
• Organizational skills with the ability to handle multiple assignments
• Strong communications skills

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.