Sr. Validation & Compliance Engineer

Job Summary We are seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated pharmaceutical/biotech manufacturing environment. The role involves developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer activities, ensuring compliance with FDA/EMA regulations, and collaborating cross‑functionally to deliver compliant and inspection‑ready systems. Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities. Author, review, and approve qualification protocols, test scripts, deviation reports, and validation summary reports. Perform risk‑based commissioning and qualification activities in alignment with FDA, EMA, cGMP, and internal quality standards. Coordinate with Engineering, Quality Assurance, Validation, Manufacturing, and Operations teams throughout the CQV lifecycle. Support technology transfer activities, process validation, and successful handover of validated systems to manufacturing. Participate in deviation investigations, root cause analysis, CAPA implementation, and continuous improvement initiatives. Ensure all validation activities are executed in compliance with GDP, data integrity, and regulatory expectations. Assist with change control assessments, periodic reviews, and maintenance of validated systems. Support inspection readiness activities and provide validation documentation during internal/external audits. Education & Experience Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline. Minimum 5+ years of experience in commissioning, qualification, and validation (CQV) within pharmaceutical, biotech, or FDA‑regulated industries. Hands‑on experience with equipment qualification, utilities validation, and facility commissioning activities. Strong knowledge of cGMP, FDA, EMA, and industry validation standards. Proven experience authoring and executing IQ/OQ/PQ protocols and validation documentation. Experience with deviation management, CAPA systems, and risk assessment methodologies. Excellent technical writing, communication, and cross‑functional collaboration skills. Familiarity with process validation, technology transfer, and manufacturing support activities preferred. #J-18808-Ljbffr