Aseptic Process Engineer: Commissioning & Validation Lead

Barrington James; Louisiana (MO); On-site; USD 110,000 - 160,000; Full time

Job summary

Barrington James is partnering with a Louisiana-based sterile compounding pharmacy to expand its manufacturing footprint. The Process Engineer will own the day‑to‑day performance of an automated aseptic filling line and lead installation, commissioning, and validation of new equipment.

You will drive uptime, yield, changeover time, and defect reduction, while coordinating with vendors and internal teams on capital projects. Strong GMP knowledge is essential.

Qualifications

• 5+ years in process, validation, or equipment engineering within sterile pharma manufacturing.
• Experience commissioning/qualification including IQ, OQ, PQ protocols.
• Knowledge of USP <797>/<795>, cleanroom aseptic processing and quality systems (change control, deviation mgmt, CAPA).
• Track record on greenfield or major capital projects through production release, familiar with GAMP 5 and 21 CFR Part 11.

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 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.

Skills

Process validation

Equipment commissioning

Sterile manufacturing

GAMP 5

IQ/OQ/PQ

Education

Bachelor's in Engineering

Tools

Colanar Equipment

Job description

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