CSV Specialist – Validation of Isolator Systems

About the role

We are seeking an experienced Computer System Validation (CSV) Specialist to lead validation activities for isolator systems within a regulated life‑sciences environment. The role focuses on ensuring automated isolator‑related systems meet GxP, 21 CFR Part 11 and Annex 11 requirements using a paper‑based approach.

Key responsibilities

• Lead and execute CSV activities for isolator systems and associated software platforms.
• Develop and review validation deliverables such as Validation Plans, VMPs, URS, FS/DS, risk assessments and IQ/OQ/PQ protocols and reports.
• Maintain traceability matrices and support the full system lifecycle from design to decommissioning.
• Apply risk‑based validation aligned with GAMP 5 and manage paper‑based documentation and approvals.
• Collaborate with engineering, automation, QA and vendors to define validation scope.
• Review vendor documentation for compliance and support deviations, CAPA and change control.
• Ensure ongoing compliance with applicable regulatory standards.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or related field.
• 3–8 years of CSV experience in pharmaceutical/biotech settings.
• Hands‑on experience with isolator system validation.
• Familiarity with automation platforms such as PLC, SCADA and HMI.
• Experience working in a paper‑based validation environment.

Required skills

• GAMP 5 methodology
• ALCOA+ data integrity principles
• 21 CFR Part 11 and Annex 11 compliance
• PLC, SCADA, HMI systems
• Risk assessment and management

What we offer

• Generous leave policy and comprehensive health & wellness coverage.
• Professional development and continuous learning programs.