Project Process Engineer
Wilson, NC (100% on-site) with travel to Shanghai, China
W2 Contract:
August 2026 – December 2027
Pay:$110-115/hr
We are seeking an experienced Project Process Engineer to support the startup, commissioning, troubleshooting, and qualification of large-scale bioprocess manufacturing equipment. This role will play a key part in bringing new production systems online at a biopharmaceutical manufacturing facility.
The position requires on-site support in Wilson, NC, along with international travel to Shanghai, China for equipment design reviews and Factory Acceptance Testing (FAT).
Responsibilities
- Lead startup, SAT, commissioning, and troubleshooting of large-scale stainless steel bioprocess equipment, including bioreactors, CIP skids, and transfer systems.
- Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment verification, and commissioning activities.
- Perform dry and wet testing of automated batch recipes and support initial production runs.
- Verify equipment installation against design drawings, P&IDs, component lists, and perform I/O validation.
- Troubleshoot process equipment and perform minor mechanical repairs, including valve diaphragms, tri-clamps, and position switches.
- Partner with Process Controls Engineers to debug and optimize control loops and update functional specifications.
- Coordinate major equipment repairs, piping modifications, and mechanical maintenance activities.
- Develop startup, commissioning, operational, and preventive maintenance documentation and SOPs.
- Document commissioning activities to support equipment qualification and validation efforts.
- Assist with qualification execution and support manufacturing readiness activities.
- Coordinate daily startup activities with production personnel and engineering teams.
Qualifications
- Experience with startup, commissioning, and troubleshooting of bioprocess manufacturing equipment.
- Hands-on experience with stainless steel bioreactors, CIP systems, transfer lines, or similar pharmaceutical process equipment.
- Knowledge of FAT, SAT, commissioning, qualification, and validation processes.
- Ability to interpret engineering drawings, P&IDs, and equipment documentation.
- Experience working in GMP or regulated pharmaceutical/biotechnology manufacturing environments.
- Strong troubleshooting and cross-functional communication skills.
- Willingness to travel internationally for equipment reviews and FAT activities.
Schedule
- August 2026 – February 2027: Part-time support
- March 2027 – December 2027: Full-time support
Beginning in April 2027, candidates must be available to work one of the following shifts:
- Sunday – Wednesday | 6:00 AM – 4:30 PM
- Sunday – Wednesday | 3:30 PM – 2:00 AM
- Wednesday – Saturday | 6:00 AM – 4:30 PM
- Wednesday – Saturday | 3:30 PM – 2:00 AM
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