CQV Engineer

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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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CQV Engineer

Job Description

• Lead and execute commissioning and qualification (C&Q) activities for Fill & Finish equipment and GMP utilities, ensuring compliance with regulatory and project requirements.
• Author and review qualification documentation, including VP, DQ, IQ, OQ, PQ, and PPQ protocols and reports.
• Perform risk assessments and develop qualification strategies for utilities (e.g., WFI, HVAC, clean steam) and drug product equipment.
• Coordinate and execute FAT/SAT and commissioning activities in collaboration with vendors and internal stakeholders.
• Manage deviations, investigations, and CAPAs related to CQV activities.
• Support shift-based execution during critical phases of commissioning and qualification.
• Ensure alignment with GMP, GAMP5, and regulatory expectations throughout the CQV lifecycle.

Requirements

• Bachelor’s or Master’s degree in Engineering or Life Sciences (Chemical, Mechanical, Pharmaceutical Engineering preferred).
• 3+ years of CQV experience in the pharmaceutical or biotech industry, with a focus on Drug Product (Fill & Finish) operations.
• Proven experience with GMP utilities (e.g., HVAC, WFI, clean steam, ammonia systems).
• Familiarity with DeltaV (Emerson) and digital validation platforms such as COMOS or KNEAT is a plus.
• Strong understanding of GMP regulations, validation lifecycle, and risk-based qualification approaches.
• Excellent communication and documentation skills in English; German is an asset.
• Ability to work in a fast-paced, cross-functional environment with a proactive and collaborative mindset.

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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.