CQV Engineer

Responsibilities

• Lead and review key CQV deliverables (URS, risk assessments , DQ, RTM, FAT/SAT, IQ/OQ) for manufacturing , facilities , utilities, and cleaning systems .
• Ensure processes are properly defined and qualified across the validation lifecycle using a risk-based approach .
• Collaborate with cross- functional teams (Engineering, Automation, E&HS, Quality ) and external partners to drive project execution .
• Support CQV activities on the ground (FAT, SAT, Commissioning, IQ/OQ) ensuring systems meet requirements .
• Manage deviations , including troubleshooting and root cause analysis .
• Ensure timely delivery of CQV documentation and maintain project schedule .
• Perform periodic reviews and requalification to ensure ongoing compliance.
• Support audit readiness and contribute to responses to regulatory inspections.
• This role offers the opportunity to play a critical part in delivering compliant, high-quality systems that directly impact patient safety and product quality in a highly regulated environment.

Requirements

• Engineering degree ( Master's preferred ) with ~8-10 years of experience in CQV/validation within regulated environments .
• Strong expertise in qualification and validation of equipment , utilities, and facilities , applying science- and risk-based approaches .
• Proven experience authoring and reviewing validation documentation, with solid knowledge of quality risk management and regulatory requirements (FDA, EMA, ICH).
• Good understanding of process equipment , utilities, automation systems (e.g., DeltaV ), and engineering principles .
• Hands-on experience in cleaning validation (sampling techniques, cycle development , MACO calculations ) and supporting New Product Introduction (NPI).
• Familiar with Computer Systems Validation (CSV) and qualification of QC equipment and systems .
• Strong problem-solving , critical thinking , and attention to detail , with the ability to manage priorities in a fast- paced environment .
• Effective communicator in English (French is a plus), able to work both independently and collaboratively across multidisciplinary teams .
• Why Sandoz?
• Generic and Biosimilar medicines are the backbone of the global medicines industry . Sandoz, a leader in this sector , provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement , we have an ambition to do more!
• With investments in new development capabilities , state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high- quality medicines , sustainably .
• The future is ours to shape !
• FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
• ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Benefits

Additional Information

T itre du poste : CVQ Engineer (H/F/D) Lieu : Toulouse Département : MSAT/CQV Relève de : Director of MSAT Type de contrat: CDI We are delighted to inform you that this opportunity is part of Sandoz's acquisition of Just- Evotec Biologics in Toulouse. This role will allow you to make a difference in the lives of hundreds of millions of people through bold ideas supported by an inclusive and agile corporate culture. Join us to help make healthcare more equitable and faster , and help us pioneer access to medicines ! Click to learn more.

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