Duration: 6 months
Job Description:
Our client is seeking an experienced CSV Engineer to join their team in Southern France onsite. In this role, you will be responsible for the design, implementation, and qualification of computer systems used in GMP environments, with a focus on developing CSV documentation from scratch or early in the new facility’s lifescycle to project completion. The ideal candidate will play a key role in ensuring regulatory compliance and data integrity across all computerized systems used in production, QC, and support functions.
Responsibilities:
- Design and implement CSV strategies and documentation in line with GAMP 5, 21 CFR Part 11, and EU GMP Annex 11.
- Develop and manage qualification lifecycle documentation (URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, SOPs).
- Collaborate cross-functionally with QA, IT, Engineering, and external vendors to ensure project alignment.
- Participate in the selection and implementation of new computer systems, including planning, testing, and commissioning.
- Conduct impact assessments for changes to existing systems and ensure re-validation when required.
- Support audits and inspections, providing evidence of compliant CSV processes.
- Maintain validation plans and ensure timely execution in line with project timelines.
- Contribute to continuous improvement of CSV procedures and standards at the site level.
Qualifications:
- Advanced degrees in Engineering, Life Sciences, IT, or related field.
- 5+ years of experience in Computer System Validation in a GMP-regulated environment.
- In-depth knowledge of CSV systems and GAMP 5, 21 CFR Part 11
- Experience in writing and executing validation protocols and working across the full system lifecycle.
- Strong project management and documentation skills.
- Ability to work cross functionally in a chaotic environment
- French and English fluency required
France: CSV Engineer (238085)
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