OverviewWe are seeking a highly experienced and detail-oriented
Aseptic FillingEngineer to join our Sterile Drug Product Engineering team.
The Aseptic Filling Engineer will be a key member of the Engineering Department and serve as the primary equipment Subject Matter Expert (SME) for sterile filling and associated manufacturing equipment. This role will be responsible for providing technical and engineering support throughout the equipment lifecycle, including design review, vendor coordination, FAT/SAT, commissioning, qualification support, start-up, troubleshooting, and ongoing performance improvement.
The ideal candidate will have strong hands-on experience with sterile injectable manufacturing processes, including aseptic filling, isolator technology, and lyophilization. The Engineer will work closely with Manufacturing, Technical Services, Validation, Quality, and external equipment vendors to ensure equipment is designed, installed, qualified, and operated in a reliable and compliant manner.
This is an individual contributor position with no direct reports.
ResponsibilitiesTechnical Oversight- Serve as the primary equipment SME for sterile filling systems, including vial and syringe filling systems, isolators, and associated lyophilization equipment.
- Provide engineering and technical support throughout the equipment lifecycle, including design review, FAT, SAT, installation, commissioning, start-up, and routine operation.
- Develop and maintain in-depth knowledge of equipment design, operating principles, control systems, critical process parameters, and equipment performance requirements.
- Lead technical troubleshooting and root cause analysis for equipment failures, performance issues, and recurring technical problems, and support implementation of effective corrective actions.
- Drive equipment reliability, performance optimization, preventive maintenance improvement, and continuous improvement initiatives in collaboration with Manufacturing and Maintenance.
- Support product technology transfer and scale-up activities.
- As a member of the global engineering team, actively connect with and contribute to DP global engineering project planning and implementation.
Regulatory Compliance- Ensure assigned equipment and engineering activities are executed in compliance with cGMP requirements, applicable regulatory expectations, and internal quality and engineering standards.
- Support regulatory inspections, customer audits, and internal audits by serving as an equipment SME.
- Partner with Quality Assurance to maintain validated state and continuous compliance of sterile manufacturing systems.
- Drive contamination control strategy implementation and support aseptic process simulation/media fill activities.
- Act as the owner of equipment maintenance procedures, spare parts management strategy, and future equipment modifications or upgrades, and support maintenance of equipment in a qualified and controlled state.
- Support deviation investigations, CAPA implementation, change control assessments, and technical impact evaluations related to sterile filling and lyophilization equipment.
Cross-Functional Collaboration and Technical Support- Work closely with Operations and Technical Services teams to support equipment readiness, process implementation, technology transfer, and new product introduction activities.
- Partner with Validation and Quality to provide engineering expertise for qualification, validation, deviation investigations, and compliance-related activities.
- Support development and execution of operator and technical training related to sterile filling and lyophilization equipment.
- Act as a key technical interface between internal departments and equipment vendors to support efficient issue resolution and long-term equipment performance.
QualificationsRequired Qualifications: - Excellent written and verbal communication skills, with attention to detail and clarity.
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline.
- Minimum of 5 years of experience in the pharmaceutical or biotechnology industry.
- Hands-on experience with sterile filling equipment, with strong knowledge of vial and/or syringe filling systems and isolator technology.
- Experience with lyophilization equipment and its integration with aseptic filling operations is strongly preferred.
- Deep understanding of cGMP requirements, risk-based approaches, and global regulatory expectations.
- Proven experience in start-up or expansion of manufacturing facilities is highly preferred.
- Strong knowledge of current Good Manufacturing Practices (cGMP), applicable FDA and EMA expectations, EU GMP Annex 1, ICH guidance, and relevant industry standards.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
