CSV Validation Specialist - Laboratory Equipment

About the role

Confidential is seeking a motivated and detail-oriented Computer System Validation Specialist (CSV) to support validation activities for laboratory equipment and computerized systems in compliance with GxP, FDA 21 CFR Part 11, and EU Annex 11. The role includes planning, executing, and documenting validation deliverables throughout the system lifecycle.

Responsibilities

• Develop and maintain Validation Plans and Validation Plan Reports.
• Create and execute IOPQ Protocols (Installation, Operational, and Performance Qualification).
• Prepare Change Control documentation and ensure proper implementation.
• Manage Traceability Matrices to ensure full requirement coverage.
• Generate and execute CSV documents.
• Coordinate release activities for validated systems.
• Collaborate with vendors for support during qualification and issue resolution.
• Ensure validation deliverables comply with internal procedures and regulatory requirements.
• Provide support during audits and inspections.

Requirements

• Bachelor’s degree in Sciences or Computer Science.
• Experience in CSV or Equipment Qualification in a GxP-regulated environment, such as pharma, biotech, or medical devices.
• Solid understanding of GAMP 5, 21 CFR Part 11, and Annex 11.
• Experience with laboratory instruments and associated software, such as LIMS, Empower, and chromatography systems, preferred.
• Experience with Change Control systems and Quality Management Systems (QMS).
• Familiarity with risk assessment methodologies, including FMEA and Risk Matrix.
• Ability to work independently and collaboratively in cross-functional teams.

Datos clave

• Job type: Contract.
• A bachelor’s degree in Sciences or Computer Science is listed as a qualification.
• Experience with laboratory instruments and associated software is preferred.