Qualification Engineer

Overview

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,/yr plus comprehensive benefits (A complete list of benefits can be found at ).

Design, write, and execute qualification protocols, tests, and reports including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for production equipment based on user, quality, technical, and functional requirements. Organize and maintain Engineering File Library. Create and revise SOPs. Maintain Lab, Manufacturing and Packaging equipment validation schedules, testing and development rollouts. Prep Change Controls; perform associate tasks in accurate, timely, effective, and compliant manner.

May undergo background checks including drug screening. Travel not exceeding 60 days per year and 5 days per trip. Provide engineering support + collaborate cross functionally w/ Ops, Packaging, and Manufacturing on qualification, programming, and troubleshooting.

Must have Bachelor s in Engineering or related field and 3 yrs relative Qualification and Validation experience 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

Salary $113, per year plus comprehensive benefits. A complete list of benefits can be found at