About the role
We are seeking a highly experienced and detail-oriented Aseptic Filling Engineer to join our Sterile Drug Product Engineering team.
What they're looking for
- 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
More about this role
We are seeking a highly experienced and detail-oriented Aseptic Filling Engineer 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.
- Serve as the primary equipment SME for sterile filling systems, including vial and syringe filling systems, isolators, and...
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