Senior Aseptic Fill-Finish Process Engineer

Harba; Indianapolis (IN); On-site; Full time

Job description

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