Sr. Process Engineer - Containment

Job Requirements

• Lead and support fill/finish manufacturing operations including vial, syringe, and/or cartridge filling in a GMP-regulated environment
• Own and execute process validation activities (IQ, OQ, PQ) for filling lines, isolators, and containment systems
• Develop, review, and approve SOPs, batch records, process descriptions, and technical protocols
• Investigate manufacturing deviations, OOS results, and equipment failures using structured root cause analysis (CAPA, fishbone, 5-Why)
• Provide technical oversight of isolator and RABS systems, including glovebox integrity testing, decontamination cycles (VHP), and leak testing
• Drive continuous improvement initiatives focused on yield, cycle time, contamination control, and operational efficiency
• Collaborate with Validation, QA, Regulatory Affairs, and Manufacturing teams to support product lifecycle activities and regulatory submissions
• Support technology transfer of new products into fill/finish operations
• Serve as the primary technical resource for filling equipment — providing troubleshooting support and directing engineering changes
• Author and review CMC sections and technical reports in support of IND, BLA, and NDA filings as needed

Job Qualifications

Required

• Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, or a related field
• 5+ years of process engineering experience in sterile fill/finish or aseptic manufacturing within a GMP environment
• Hands-on experience with containment systems — isolators and/or RABS — including VHP bio-decontamination
• Strong working knowledge of aseptic processing principles, contamination control strategies, and sterility assurance
• Experience authoring and executing validation protocols (IQ/OQ/PQ) and process qualification studies
• Solid understanding of FDA, EU Annex 1, and ICH guidelines relevant to sterile drug product manufacturing
• Demonstrated ability to lead deviation investigations and drive CAPA to closure
• Strong technical writing skills — SOPs, batch records, engineering reports, regulatory documentation

Preferred

• Experience with biological drug products (mAbs, vaccines, gene therapy, or other biologics) in fill/finish
• Familiarity with lyophilization processes and cycle development
• Exposure to technology transfer from clinical to commercial scale
• Experience supporting FDA, EMA, or other regulatory agency inspections
• Knowledge of lean manufacturing, Six Sigma, or other process improvement methodologies
• Familiarity with equipment qualification for automated visual inspection (AVI) systems
• Experience in a CDMO or multi-product manufacturing environment