What are the responsibilities and job description for the Senior Process Engineer position at Fusion Life Sciences Technologies LLC?
Senior Process Engineer – Pharmaceutical Manufacturing
Location: Greenville, NC
Work Arrangement: Onsite
Contract Duration: 12 Months
Job Type: Contract
Position Overview
Our client, a growing pharmaceutical CDMO, is seeking a Senior Process Engineer to drive process improvements across the manufacturing site. The ideal candidate will have hands-on experience with aseptic processing, automated vial filling equipment, isolators, and cGMP manufacturing environments.
Key Responsibilities
- Optimize fill line and isolator performance to improve reliability, efficiency, and throughput.
- Troubleshoot aseptic processing and manufacturing issues in a cGMP environment.
- Support and improve EMA and Optima filling lines, including automated vial filling equipment.
- Investigate process deviations and equipment/process performance issues and implement effective corrective actions.
- Support formulation, filling, and autoclave operations.
- Partner with Manufacturing, Engineering, Quality, Maintenance, and other cross-functional teams.
- Identify opportunities for continuous improvement, process optimization, and reliability enhancement.
- Develop, revise, and maintain SOPs, batch records, work instructions, and other process documentation.
- Provide hands-on technical support in a fast-paced pharmaceutical manufacturing environment.
- Apply engineering principles and data-driven problem-solving to improve process performance and equipment reliability.
Required Skills & Experience
- Strong experience in Process Engineering within pharmaceutical/biopharmaceutical manufacturing.
- Hands-on experience with aseptic processing and troubleshooting.
- Experience with automated vial filling/fill-finish operations.
- Experience with Optima H610 filling equipment strongly preferred.
- Experience with EMA fill lines preferred.
- Understanding of isolator systems and associated support equipment.
- Familiarity with autoclave processes and formulation/filling operations.
- Strong understanding of cGMP requirements.
- Experience creating and maintaining SOPs, batch records, and process documentation.
- Strong troubleshooting, root-cause analysis, and continuous improvement skills.
- Reliability Engineering experience is a plus.
- Ability to work onsite in Greenville, NC.