Qualification Engineer

Overview

Description

Qualification Engineer for Tris Pharma, Inc to work at Monmouth Junction, NJ loc. Support and assist facilities and engineering dept with writing and execution of qualification protocols for production and utilities equipment to meet production requirements including deadlines, and compliance with SOPs, cGMPs, and FDA. Work cross functionally with Ops and Manufacturing to maintain qualification status of systems, lead improvement projects, and initiatives to increase efficiency and productivity of manufacturing processes.

Qualification Engineering includes writing protocols and reports complying with cGMPs, SOPs, and FDA. Provide documented evidence that company equipment is qualified and remains in state of control to deliver processes and products complying with regulatory and business specs. Provide engineering support and collaborate cross functionally with Ops, Packaging, and Manufacturing on qualification, programming, and troubleshooting. 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. Prepare Change Controls and perform associate tasks in an accurate, timely, effective, and compliant manner. May undergo background checks including drug screening. Little national and international travel to manufacturers’ sites for equipment testing not exceeding 60 days per year and 5 days per trip may be involved.

Salary $113,173 – 158,070/yr plus comprehensive benefits (A complete list of benefits can be found at ).

Requirements

Must have Bachelor’s in Engineering or related field and 3 years related Qualification and Validation experience in pharma or biotech. Also requires skills (3 years experience) 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