CSV Lead Engineer
Capgemini
- Bern
- Unbefristet
- Vollzeit
Get the Future You Want |Follow your passion in a role where you will be exposed to the technologies and processes that leading global companies utilize, and join our innovative team as,CSV Lead EngineerResponsibilities
- Leads CSV commissioning & qualification activities to achieve defined scheduled production start dates.
- Generates and executes (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix. Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5.
- Perform Computer System Validation and other duties as assigned.
- Advanced knowledge of discipline; able to discuss regulatory expectations for validation activities, program and documentation.
- Demonstrated ability to plan and organize validation activities among cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
- Capable of independently discussing computer systems validation philosophies.
- Bachelor's or Master's Degree in Engineering (Chemical, Mechanical, Process, Pharmaceutical, Biochemical Engineering or equivalent) or long time and in-depth project technical management or operational experience in international environments.
- Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...).
- Minimum 2 years' experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.
- Technical writing of commissioning and validation documentation for large scale CAPEX projects.
- Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
- Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
- Fluency in English, German would be an asset.
Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.
Capgemini is an EEO and Affirmative Action Employer of Females/Minorities/Individuals with Disabilities.Our offer
- A permanent contract with the leader in innovation and high-tech engineering consulting.
- A multi-stage model with career opportunities through specialization prospects with over 250'000 consultants around the world and a Group revenue of EUR. 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D).
- In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva.
- Capgemini Engineering will be on the forefront in creating an optimal work-life balance, more autonomy in where and how our people work and to embrace the learnings we have experienced from wider-scale remote working. For you, this may mean less time in the office than usual with some time working from home, whereas other roles and engagements will continue to be more location-dependent or office-based. Together with your manager, you will agree an approach which works for you, your team and our business.
- In order to deploy this novel way of working, we have introduced our New Normal policy which includes: 30% to 70% remote work in agreement with your line manager and client needs; Trust-based managerial culture; Team rituals and get together; Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.