Validation EngineerWe're seeking a Validation Engineer to work with one of our top global biopharmaceutical clients in the Anasco, PR area. The Validation Engineer will support and execute validation activities for manufacturing processes, equipment, cleaning, and computerized systems in a regulated environment.
The role ensures compliance with applicable regulatory requirements (FDA, ISO, cGMP) and internal quality standards. The ideal candidate has 2–5 years of experience in validation within the medical device, pharmaceutical, or similarly regulated industry.ResponsibilitiesDevelop, execute, and document validation protocols and reports, including: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)Support process validation activitiesParticipate in equipment qualification and requalification activities.Perform validation impact assessments for changes (Change Control/CN/CR).Collaborate with cross-functional teams (Manufacturing, Quality, R&D, Engineering, Regulatory).Ensure compliance with applicable regulationsAnalyze data using statistical tools (e.g., Minitab, Excel) to support validation conclusions.Assist in protocol deviations, investigations, and corrective actionsMaintain accurate and complete documentation in accordance with GDP (Good Documentation Practices).Support audits and regulatory inspections by providing validation documentation.Track and report validation project status, timelines, and deliverables.