Senior Validation Engineer

Key Responsibilities: Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP regulated assets Oversee validation activities for internal and client tech transfer projects, including authoring and executing validation documents Provide technical mentorship and guidance to junior validation staff while collaborating cross-functionally to align validation activities with project timelinesRequired QualificationsBachelor's degree in a life science, engineering, or related technical field 7-11 years of experience in the biotech, pharmaceutical, or medical device industry Strong knowledge of FDA cGMP requirements and risk-based validation principles Advanced validation expertise in equipment, computerized systems, and process validation Experience supporting audits and regulatory inspections