
Senior Project Quality Engineer – Pharmaceutical Industry
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Office
Location: Cormelles-le-Royal • France
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Job Level
About the role
- As a Project Quality Consultant, you will play a central role in overseeing quality activities for industrial projects (revamps, transfers, scale‑up, new equipment).
- You will work at the interface with technical teams, QA and Engineering to ensure GMP compliance throughout the project lifecycle.
- Define and implement quality requirements within the scope of technical projects.
- Participate in project risk analyses (FMEA, HAZOP, functional analysis).
- Contribute to project-related qualifications/validations: IQ/OQ/PQ, change control, protocols and reports.
- Manage and track deviations, CAPAs and changes associated with project developments.
- Write and update quality documents (procedures, work instructions, project quality plans).
- Prepare projects for regulatory audits and inspections.
- Coordinate interactions between QA, Engineering, Production and Development.
- Ensure GMP compliance at every stage: design, installation, commissioning, validation, transfer.
Requirements
- Master’s degree in Quality, Pharmacy, Biotechnology, Chemistry or an equivalent discipline.
- Minimum 8 years’ experience in Project Quality, Operational QA or Pharmaceutical Engineering.
- Strong understanding of GMP, FDA CFRs, ICH guidelines and project standards (e.g., ISPE Baseline Vol. 5).
- Demonstrated experience on technical projects (transfers, equipment, utilities, processes).
- Ability to manage project quality documentation and to lead validation activities.
- Professional proficiency in English.
- Experience in sterile environments is a plus.
Benefits
- Cutting-edge expertise: contribute to strategic projects alongside leading global innovators in high-impact sectors (future energies, biotechnologies, AI, 5G/6G, autonomous vehicles).
- Inclusive environment: join engaged networks such as Women@Capgemini, Parents@Capgemini, OUTfront or CapAbility, and work in an EDGE+ certified environment recognized by the Bloomberg Gender-Equality Index.
- Career development: build your path through numerous development levers designed for you (training programs, certifications, mobility, masterclasses, etc.).
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP complianceFMEAHAZOPIQ/OQ/PQchange controlproject quality documentationvalidation activitiesquality requirements definitionrisk analysisdeviation management
Soft Skills
communicationleadershiporganizationalcollaborationproblem-solving
Certifications
Master’s degree in QualityMaster’s degree in PharmacyMaster’s degree in BiotechnologyMaster’s degree in Chemistry