Capgemini is looking for a Quality Project Engineer to play a central role in quality oversight for industrial projects, including revamping, transfers, scale-ups, and new equipment. You will act as the interface with technical, QA, and Engineering teams to guarantee GMP compliance throughout the entire project lifecycle.
What You'll Do
- Define and implement quality requirements within technical projects.
- Participate in project risk analyses such as FMEA, HAZOP, and functional analysis.
- Contribute to project-related qualifications and validations, including IQ/OQ/PQ, change control, and protocol and report writing.
- Manage and track deviations, CAPA, and changes associated with project evolutions.
- Write and update quality documents, including procedures, instructions, and 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, and transfer.
What We're Looking For
- Master's degree (Bac+5) in quality, pharmacy, biotechnology, chemistry or equivalent discipline.
- Minimum 8 years of experience in project quality, operational QA, or pharmaceutical engineering.
- Strong understanding of GMP, FDA CFR, ICH, and project standards such as ISPE Baseline Guide Volume 5.
- Demonstrated experience with technical projects involving transfers, equipment, utilities, and processes.
- Ability to manage project quality documentation and drive validation activities.
- Professional proficiency in English.
Nice to Have
- Experience in a sterile environment is a plus.
Benefits & Compensation
- Leading-edge expertise: Contribute to strategic projects alongside global innovators in high-impact sectors like future energies, biotechnology, AI, 5G/6G, and autonomous vehicles.
- Inclusive environment: Join engaged networks such as Women@Capgemini, Parents@Capgemini, OUTfront, or CapAbility, and grow in a framework certified EDGE+ and recognized by the Bloomberg Gender Equality Index.
- Career development: Build your path through numerous dedicated levers including training paths, certifications, mobility opportunities, and masterclasses.
Capgemini encourages an inclusive culture in a multicultural and accessible environment, valuing diversity, developing talent, engaging in solidarity initiatives, and reducing its environmental impact.
