What are the responsibilities and job description for the Process Engineer position at Barrington James?
Currently partnered with a Louisiana-based sterile compounding pharmacy is expanding its manufacturing footprint and looking for a Process Engineer to help bring new capacity online. You'll own the day-to-day performance of an automated aseptic filling line and lead the installation, commissioning, and validation of new production equipment.
Job Responsibilities
- Own performance of an automated aseptic filling system, driving uptime, yield, changeover time, and reject rate improvements
- Lead commissioning and qualification for new capital equipment, from factory/site acceptance testing through IQ, OQ, and PQ
- Author, execute, and close out validation protocols, URS, and traceability matrices
- Partner with vendors, contractors, and internal teams on facility buildout, covering layout, utility tie-ins, and installation readiness
- Manage equipment calibration, preventive maintenance, and investigate equipment-related deviations and OOS results
- Support media fill programs, environmental monitoring, cleaning validation, and change control tied to equipment
- Own equipment documentation: SOPs, batch records, training, and audit-readiness for state board, NABP, and FDA inspections
Job Requirements
- Bachelor's degree in Mechanical, Chemical, Biomedical, Pharmaceutical, or related engineering discipline; equivalent hands-on experience considered
- 5 years in process, validation, or equipment engineering within sterile compounding, pharma manufacturing, biotech, or medical device
- Demonstrated ownership of commissioning/qualification work, including authoring and executing IQ, OQ, PQ protocols, plus hands-on experience with automated production equipment (aseptic filling, autoclaves, sterile filtration)
- Working knowledge of USP <797>/<795>, cleanroom/aseptic processing, and quality systems (change control, deviation management, CAPA)
- Track record taking a greenfield or major capital project through to production release, with familiarity in GAMP 5 and 21 CFR Part 11
- Experience working with Colanar Equipment