Computer System Validation Engineer

About the role

Validation & Engineering Group is seeking a Computer System Validation Engineer to lead periodic reviews of roughly 42 computerized systems that support QC and QA operations in the pharmaceutical and biotechnology sectors. The role ensures systems remain compliant, data‑integrity is maintained, and they continue to be fit for their intended use.

Key responsibilities

• Plan and execute periodic reviews of computerized systems according to approved schedules and procedures.
• Review validation and lifecycle documentation, including intended use, configuration, validation plans, testing reports, change controls, incidents, CAPAs, and audit trails.
• Assess compliance with cGMP, data‑integrity, ALCOA+ and 21 CFR Part 11 requirements and document conclusions, risks and remediation actions.
• Support deviations, CAPAs, change controls and investigations involving computerized systems.
• Collaborate with system owners, Quality, IT, automation and laboratory teams and provide documentation for audits and inspections.

Required profile

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences or related field.
• Five or more years of computerized system validation experience in pharmaceutical or biotechnology operations.
• Strong knowledge of risk‑based CSV, data integrity, ALCOA+ principles, 21 CFR Part 11 and GAMP practices.

Required skills

• Experience with laboratory or quality platforms such as LIMS, Maximo, TrackWise, PI Historian, RIM, QBMS.
• Proficiency in preparing audit‑ready documentation using Kneat, CDOCs or equivalent platforms.
• Ability to conduct periodic system reviews, evaluate security roles, backup/restore processes and vendor support status.