Senior Process Engineer

Key Responsibilities Provide technical leadership and process engineering support for aseptic fill-finish manufacturing operations within a GMP-regulated pharmaceutical environment Support filling, compounding, formulation, and sterile processing operations to ensure reliable and compliant manufacturing performance Lead process optimization, troubleshooting, and continuous improvement initiatives focused on fill-finish equipment, aseptic processes, and manufacturing efficiency Partner cross-functionally with Manufacturing, Quality, Validation, Maintenance, Engineering, and Technical Operations teams to support production goals and operational readiness Support investigations, root cause analysis, CAPAs, deviations, and change control activities related to fill-finish manufacturing processes and equipment Develop and revise SOPs, batch records, engineering documentation, and technical reports to support manufacturing and compliance activities Assist with equipment qualification, process validation, media fills, and technology transfer activities for aseptic manufacturing systems Monitor process performance data and identify opportunities to improve throughput, reduce downtime, and enhance process robustness Provide engineering oversight for filling lines, isolators, sterilization systems, single-use technologies, and other fill-finish equipment Support commissioning, startup, and implementation of new manufacturing equipment and process improvements within sterile production environments Collaborate with site leadership and operational teams to ensure manufacturing activities align with safety, quality, and production objectives Participate in audits, regulatory inspections, and compliance readiness activities related to aseptic processing and fill-finish operations Qualifications 5+ years of process engineering experience within pharmaceutical, biotech, or other GMP-regulated manufacturing environments Hands‑on experience supporting aseptic fill‑finish, sterile manufacturing, or injectable drug product operations required Strong knowledge of aseptic processing, sterile techniques, GMP compliance, and pharmaceutical manufacturing standards Experience supporting filling equipment, isolators, autoclaves, CIP/SIP systems, formulation equipment, or other sterile manufacturing technologies preferred Demonstrated experience leading process improvements, equipment troubleshooting, investigations, and manufacturing support activities Familiarity with validation lifecycle activities including IQ/OQ/PQ, process validation, and media fill execution preferred Strong technical writing and documentation skills with experience authoring SOPs, deviations, CAPAs, change controls, and engineering reports Ability to work cross‑functionally in a fast‑paced manufacturing environment while managing multiple priorities and deadlines Experience utilizing data analysis and process monitoring tools to support operational performance and continuous improvement initiatives Lean Manufacturing, Six Sigma, or other continuous improvement experience is a plus Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field preferred #J-18808-Ljbffr Harba