Sr. Validation Engineer

Role: Senior Validation Engineer leading validation activities in GMP-regulated environments for equipment, utilities, facilities, and manufacturing processes. Main objectives include developing, executing, and managing validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) to ensure regulatory compliance. Responsibilities encompass overseeing validation projects, authoring validation protocols and reports, conducting P&ID walkdowns, thermal mapping, and supporting audits and regulatory inspections. Qualifications: Bachelor's in life sciences, engineering, or related field; 7–11 years in biotech/pharma/medical device industries; expert knowledge of FDA cGMP, risk-based validation principles, and computerized systems validation (CSV). Preferred skills include strong communication, organization, problem-solving, and mentorship capabilities. High-value specifics: focus on equipment and process validation, CSV, supporting regulatory inspections, and working within GMP environments. Work setup involves a combination of on-site and remote work with some physical demands such as lifting up to 25 pounds, primarily in an office or lab environment.