Qualification Engineer

Tris Pharma Inc•South Brunswick, NJ

10h

About The Position

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.
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
MS Office suite, including Project

Responsibilities

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.