Process Engineering Senior

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

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