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 #J-18808-Ljbffr