Validation Engineer

Lead lifecycle Commissioning and Qualification (CQV) activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Author, review, and execute validation protocols and reports for multi-use and single-use manufacturing systems. Develop and maintain key validation documents, including: Risk Assessments (FMEA / Risk-Based Validation) Traceability Matrices (RTM) Validation Summary Reports (VSR) Deviation Reports and CAPAs Collaborate with automation and engineering teams to ensure synchronization between physical equipment and automated control systems. Support validation of integrated GMP systems, including automation platforms and electronic documentation systems. Apply risk-based validation approaches in alignment with ASTM E2500 principles. Ensure compliance with 21 CFR Part 11, Data Integrity (ALCOA+), GAMP 5, and current industry best practices. Drive validation activities independently in a fast-paced manufacturing environment. Required Qualifications Minimum 6+ years of CQV and/or CSV experience within the life sciences industry. Strong hands-on experience executing IQ/OQ/PQ for GMP-regulated manufacturing equipment. Proven experience validating biologics manufacturing systems such as: Bioreactors TFF (Tangential Flow Filtration) systems Chromatography systems CIP/SIP systems Filtration skids Experience with deviation management and regulatory audit readiness. Strong technical writing and documentation skills. Ability to work independently with minimal oversight. #J-18808-Ljbffr