CSV Consultant – Life Sciences Validation

About the role

Fortil is seeking a CSV Consultant to join a strategic project focused on validating computerized systems used in the Life Science sector. You will work on ensuring compliance with GxP regulations and supporting remediation and re‑qualification activities.

Key responsibilities

• Validate laboratory instrumentation control, automation, and quality systems (ERP, LIMS, DMS) according to GxP and GAMP guidelines.
• Support remediation or re‑qualification projects to align systems with FDA 21 CFR Part 11, EU Annex 11, and data‑integrity regulations.
• Perform periodic reviews of computerized systems and user audit trails.
• Draft validation documentation such as Validation Plans, URS, Traceability Matrices, and test protocols (IQ/OQ/PQ).
• Prepare risk assessments and system administration procedures.

Required profile

• Bachelor's or Master's degree in engineering, chemistry, pharmacy, biology or related field.
• Minimum 3 years of experience on CSV projects in the Life Science industry.
• Proven ability to map data flows and conduct gap analyses for compliance improvement.
• Strong knowledge of GMP, FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP5, and data‑integrity guidelines (MHRA, WHO, EMA, FDA).
• Fluent written and spoken English and proficient with Microsoft Office.

Required skills

• GAMP5 methodology
• FDA 21 CFR Part 11 compliance
• EU Annex 11 compliance
• Data‑integrity regulations (MHRA, WHO, EMA, FDA)
• ICH Q9 risk‑management
• Mapping data flows and gap analysis
• Validation planning (IQ, OQ, PQ)
• Risk assessment documentation
• Microsoft Office suite

What we offer

• Personalized support for skill development
• An ecosystem encouraging growth beyond comfort zones
• Opportunity to become a shareholder
• Involvement in community and non‑profit projects
• Dedicated policy supporting parenthood
• Equal‑opportunity workplace inclusive of all backgrounds