Validation Engineer

Role: Validation Engineer responsible for developing and executing validation protocols to ensure quality compliance across processes, facilities, and systems within a biopharma setting. Primary objectives include defining, implementing, and maintaining validation programs, supporting client validation activities, and ensuring regulatory adherence. Responsibilities encompass generating lifecycle documentation (FAT, SAT, IQ, PQ) for equipment, utilities, and processes; writing and reviewing validation master plans, SOPs, protocols, and reports; supporting validation execution through walkdowns, thermal mapping, and troubleshooting; and assisting with regulatory audit responses and requalification activities. Requirements: Bachelor's in a life science field; 3-10 years’ experience in biotech, pharma, or medical devices; knowledge of FDA cGMP, FMEA, risk analysis; expertise in Process Equipment, Utilities, Clean Rooms, or Computer System validation; strong documentation skills. Preferred skills include hands-on equipment start-up, troubleshooting, and effective communication for technical and non-technical stakeholders. High-Value: Experience with validation for biotech manufacturing, focusing on process validation, equipment qualification, and regulatory compliance in a cGMP environment. Work setup: likely office-based with some site support; physical demands include use of computer, walking, and lifting up to 25 lbs; environment is indoor, moderate noise, typical for validation activities.