Tris Pharma · 4 days ago
Qualification Engineer
Monmouth Junction, NJ
Full-time
Onsite
Mid Level
$113K/yr - $158K/yr
3+ years expTris Pharma, Inc is seeking a Qualification Engineer to support and assist the facilities and engineering department in writing and executing qualification protocols for production and utilities equipment. The role involves cross-functional collaboration to maintain qualification status and improve manufacturing processes while ensuring compliance with regulatory standards.
BiotechnologyLife ScienceManufacturingMedicalPharmaceutical
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
Qualification
Required
Bachelor's in Engineering or related field
3 years relevant Qualification and Validation experience in pharma or biotech
3 years experience in manufacturing systems
3 years experience with regulatory and manufacturing SOPs and cGMPs
3 years experience designing, writing, and executing 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
Ability to read and interpret safety and environmental policy documents, operating and maintenance instructions, and procedure manuals
Experience maintaining Laboratory, Manufacturing, and Packaging equipment validation schedules, testing, and developmental rollouts
Experience preparing Change Controls
Proficiency in MS Office suite, including Project
Benefits
Comprehensive benefits
Company
Tris Pharma
Tris Pharma is a pharmaceuticals company providing specialty generic products.
501-1000 employees
H1B Sponsorship
Tris Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (21)
2023 (20)
2022 (17)
2021 (16)
2020 (33)
Funding
Current Stage
Late StageTotal Funding
$141.6MKey Investors
National Institute on Drug Abuse (NIDA)Deerfield
2023-08-28Grant· $16.6M
2018-10-05Debt Financing· $125M
Leadership Team
Franchesca M. Fowler
General Counsel, Sr. Vice President and Chief Compliance Officer
J
James Hackworth
President, Brand Division
Recent News
Company data provided by crunchbase