Sr. Validation Engineer

Role: Senior Validation Engineer responsible for leading validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated biopharma environments. Objectives include ensuring compliance with FDA cGMP, 21 CFR Part 11, data integrity, and quality standards through lifecycle management of validation documentation. Responsibilities encompass developing and executing validation protocols (IQ, OQ, PQ), overseeing MES/eBR system qualification and lifecycle, reviewing validation requirements, and supporting regulatory audits and remediation efforts. The role involves close collaboration with Manufacturing, Quality, Validation, Automation, and IT/OT teams to facilitate technology transfer, system deployment, and ongoing compliance. Qualifications: BSc in Engineering, Life Sciences, or related field; 7-11 years of experience in biotech, pharma, or medical device sectors. Proven expertise in equipment and process validation, computerized systems validation (including MES platforms like PAS-X, PharmaSuite), and regulatory compliance. Preferred skills include strong documentation, risk assessment, and cross-functional collaboration, with experience supporting audits and regulatory inspections. High-value specifics: experience with MES/eBR systems, validation lifecycle management in GMP settings, and supporting technology transfer activities. Work setup: Not specified, but typical GMP validation environment often involves office and manufacturing site interactions.