Qualification Engineer

Overview

Qualification Engineer for Tris Pharma, Inc to work at Monmouth Junction, NJ. Support and assist the facilities and engineering department 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 Operations and Manufacturing to maintain the qualification status of systems, and to lead improvement projects and initiatives to increase efficiency and productivity of manufacturing processes.

Design, write, and execute qualification protocols, tests, and reports—including Installation Qualification, Operational Qualification, and Performance Qualification—for production equipment based on user, quality, technical, and functional requirements. Organize and maintain the Engineering File Library; create and revise SOPs; maintain laboratory, manufacturing, and packaging equipment validation schedules, testing, and developmental rollouts; prepare change controls and perform associated 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). Salary $113,173 – $158,070 per year plus comprehensive benefits (A complete list of benefits can be found at ).

• Must have a Bachelor’s in Engineering or related field.
• Minimum 3 years of relevant Qualification and Validation experience in pharma or biotech.
• 3+ years of experience in manufacturing systems.
• Experience with regulatory and manufacturing SOPs and cGMPs.
• 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.
• 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.
• Proficient in MS Office suite, including Project.