Validation Engineer

Summary: This is a hands-on, onsite role focused on equipment installation, IQ/OQ execution, and validation documentation within a regulated manufacturing environment (ISO 9001 / ISO 13485). The team is looking for someone who can support qualification activities as the equipment comes online. The role works directly with the Manufacturing Engineering Manager and is execution-focused - ideal for someone who enjoys being on the floor, owning validation deliverables, and supporting equipment readi

Roles & Responsibilities: Writing and execution of validation protocols and reports (ie. IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system. Working with OEM equipme

Roles & Responsibilities: Support process engineering activities including investigations, process improvement initiative, and process transfers for new product introductions. This person will play a key role in introducing a new production line onsite, bringing strong media fill experience to develop and implement and implement a comprehensive media fill strategy to support aseptic manufacturing readiness. Responsibilities include supporting stability and technical transfers for both new and ex

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description As part of the Thermo Fisher Scientific t