Validation Engineer

Own validation and qualification activities for manufacturing equipment, utilities, facilities, and production support systems within a regulated pharmaceutical environment. Prepare and execute validation lifecycle documentation including validation plans, user requirements, risk assessments, qualification protocols, and final reports. Lead commissioning and qualification efforts for new equipment installations and manufacturing projects from planning through operational release. Perform and document FAT, SAT, IQ, OQ, and performance qualification testing while resolving issues identified during execution. Support qualification of sterile manufacturing equipment, cleanrooms, critical utilities, and environmental control systems. Execute cleaning validation activities, temperature mapping studies, and requalification efforts for existing manufacturing systems. Investigate deviations, support root cause analysis, and implement corrective actions through change controls and CAPA processes. Develop, revise, and maintain validation procedures, SOPs, and other GMP documentation. Partner with Engineering, Manufacturing, Quality, and equipment vendors to ensure successful startup and qualification of new systems. Provide validation support during internal audits, regulatory inspections, and continuous improvement initiatives. Coordinate multiple validation projects while tracking priorities, timelines, and deliverables. Preferred Qualifications: Bachelor's degree in Engineering, Life Sciences, or another technical discipline. Three or more years of experience performing validation or commissioning and qualification activities in a GMP-regulated manufacturing environment. Demonstrated experience authoring and executing qualification documentation such as URS, risk assessments, FAT/SAT, IQ/OQ/PQ, and validation reports. Hands‑on experience qualifying manufacturing equipment, facilities, utilities, laboratory systems, or cleanroom environments. Understanding of sterile or aseptic manufacturing operations, including equipment used in pharmaceutical production. Experience with cleaning validation, controlled temperature unit qualification, or temperature mapping is highly desirable. Working knowledge of GMP documentation practices, deviations, CAPAs, investigations, and change management. Strong technical writing, problem‑solving, and cross‑functional communication skills. Comfortable working directly on the manufacturing floor during equipment startup, qualification, and production support activities. #J-18808-Ljbffr