Qualification Engineer

Description

Qualification Engineer for Tris Pharma, Inc to work at Monmouth Junction, NJ loc. Support + assist facilities + engineering dept w/ writing + execution of qualification protocols for production + utilities equipment to meet production requirements including deadlines + compliance w/ SOPs, cGMPs, and FDA. Work cross functionally w/ Ops + Manufacturing to maintain qualification status of systems + improvement projects + initiatives to increase efficiency + productivity of manufacturing processes. Qualification Engineering including writing protocols + reports complying w/ cGMPs, SOPs, + FDA. Support + assist Engineering qualification function by providing documented evidence that company equipment is qualified + remains in state of control to deliver processes + products complying with regulatory + business specs. Provide engineering support + collaborate cross functionally w/ Ops, Packaging, + Manufacturing on qualification, programming, + troubleshooting. Design, write, and execute qualification protocols, tests, + reports including Installation Qualification, Operational Qualification, + Performance Qualification for production equipment based on user, quality, technical + functional requirements. Organize + maintain Engineering File Library. Create + revise SOPs. Maintain Lab, Manufacturing, + Packaging equipment validation schedules, testing + development rollouts. Prep Change Controls + perform associate tasks in accurate, timely, effective, + compliant manner. May undergo background checks including drug screening. Little national and international travel to manufacturers' sites for equipment testing not exceeding 60days/yr and 5 days/trip may be involved. Salary $113,173 - 158,070/yr plus comprehensive benefits (A complete list of benefits can be found at trispharma.com/connect/careers).

Requirements

Must have Bachelor's in Engineering or rel field and 3 yrs rel Qualification and Validation exp in pharma or biotech. Also requires skills (3 yrs exp) in: manufacturing systems; regulatory and manufacturing SOPs and cGMPs; designing, writing, and executing qualification protocols, tests and reports to include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for production equipment based on user, quality, technical and functional requirements; reading and interpretation of safety and environmental policy documents, operating and maintenance instructions and procedure manuals; Maintaining Laboratory, Manufacturing and Packaging equipment validation schedules, testing and developmental rollouts; Preparing Change Controls; and MS Office suite, including Project. Apply at https://www.trispharma.com/connect/careers/.