About the Role

We are seeking a mid-level Computer System Validation (CSV) Engineer to join our project team on a 6-month contract. The successful candidate will be heavily involved in the execution phase of the project, delivering validation of GxP computerized systems in line with regulatory and project requirements. The role focuses on preparing and executing test protocols, ensuring compliance with 21 CFR Part 11, Annex 11, and relevant data integrity standards.

Key Responsibilities

• Plan, execute, and document CSV deliverables including IQ, OQ, and PQ testing.

• Author and execute validation protocols, test scripts, reports, and traceability matrices.

• Ensure computerized systems meet GxP and data integrity requirements.

• Support troubleshooting, deviations, and issue resolution during validation execution.

• Collaborate with system owners, QA, IT, and vendors to ensure timely delivery of CSV milestones.

• Contribute to risk assessments and impact assessments for GxP computerized systems.

• Ensure validation activities align with regulatory standards (FDA, EMA, EU Annex 11, GAMP 5).

• Participate in daily project meetings and report on validation progress.

Qualifications & Experience

• Degree in Computer Science, Engineering, Life Sciences, or a related discipline.

• 3–6 years’ experience in CSV within pharma or biotech environments.

• Strong working knowledge of GAMP 5, Annex 11, and 21 CFR Part 11.

• Proven experience in executing IQ/OQ/PQ protocols for GxP computerized systems.

• Experience with deviation handling, CAPAs, and change controls.

• Strong technical documentation and communication skills.

• Fluency in French is essential; working proficiency in English is a strong advantage.