Validation Engineer

Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety.

As a Validation Engineer you will be responsible for executing commissioning, qualification, and validation activities for equipment, utilities, facilities, and computerized systems in a GMP-regulated pharmaceutical environment. The role supports the full validation lifecycle, including protocol development and execution (IQ/OQ/PQ), deviation management, CSV documentation, and coordination with Quality, Engineering, and external contractors to ensure compliance and inspection readiness.

• Perform routine commissioning, qualification, and validation (CQV) tasks, including temperature mapping and related validation activities.
• Develop and execute validation protocols for equipment, utilities, facilities, and computerized systems, including IQ, OQ, PQ, and validation plans.
• Investigate deviations and exceptional conditions, implementing corrective and preventive actions (CAPAs) to resolve issues.
• Assist with calibration and certification of validation instruments to maintain accuracy and compliance.
• Review and approve technical documentation such as protocols, summary reports, test records, and validation SOPs.
• Create and maintain Computerized System Validation (CSV) documents like risk assessments, validation plans, user acceptance tests (UATs), and final reports.
• Collaborate with Quality Engineering to establish and update validation strategies and standard procedures.

• MBO level 4 with at least 4 years of relevant experience, or HBO with at least 3 years of experience.
• Proven GMP experience within the pharmaceutical or related industries.
• Prior validation experience in a regulated environment.

Apply to our vacancy for more information. Looking forward to hearing from you.