CQV Engineer

Titre du poste : CVQ Engineer (H/F/D)

Lieu : Toulouse

Département : MSAT/CQV

Relève de : Directeur 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.

What You’ll Do:

• 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 responding 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.

Who You Are:

• 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 Q/C 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 a plus), able to work both independently and collaboratively across multidisciplinary teams.

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.