- 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.
- 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.
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CSV Lead Engineer - Bern, Schweiz - Capgemini
Beschreibung
About us
World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defence, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 340,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fuelled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.
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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 Engineer
Responsibilities
Requirements
If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful.
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.
