Sr. Validation Engineer

Role: Senior Validation Engineer leading validation activities within GMP-regulated biopharma manufacturing environments, focusing on equipment, utilities, facilities, and computerized systems. Responsibilities: develop and execute validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ), oversee technical transfer projects, prepare validation reports, support regulatory audits, and mentor junior staff. Qualifications: Bachelor's in life sciences, engineering, or related field; 7-11 years in biotech/pharma with expertise in cGMP, FMEA, risk-based validation, and computerized system validation. High-Value: strong experience with equipment, CSV, analytical/Process validation, FDA compliance, and supporting audits. Collaboration: cross-functional team engagement, internal and client validation projects. WorkSetup: not specified, but likely office-based with field support; physical demands include typical office activity and light lifting.