Our client is seeking an experienced Process Engineer for API manufacturing activities to provide technical engineering support for manufacturing operations within a regulated production environment.
This individual will be responsible for optimizing manufacturing processes, troubleshooting equipment issues, and supporting process improvements to enhance safety, quality, and productivity.
The role will involve process scale-up, equipment startup, manufacturing documentation, and supporting day-to-day production activities while ensuring compliance with established safety and quality standards.
Responsibilities include leading technical investigations, supporting equipment qualification, developing batch records, and collaborating with cross-functional teams to resolve manufacturing challenges. The ideal candidate has a strong chemical engineering background, hands-on manufacturing experience, and the ability to independently manage engineering activities with minimal oversight.
- 5+ years of process engineering or related API manufacturing experience, hands-on experience with GMP process troubleshooting, process optimization, equipment startup, technical documentation, and process safety.
- Equipment knowledge such as reactors, centrifuges, dryers, mills, etc.
Bonus / Nice to Have:
- PHA/PSSR, CAPA investigations, equipment qualification, P&IDs, mass balance calculations, and emission calculations
- Provide technical engineering support for manufacturing processes, including process scale-up, equipment startup, troubleshooting, and production optimization.
- Develop and revise manufacturing documentation, including batch records, work instructions, cleaning procedures, and GMP-related documentation.
- Lead process improvement initiatives to reduce downtime, improve cycle times, and enhance manufacturing safety, quality, and productivity.
- Support equipment setup, facility and equipment qualification, product changeovers, and manufacturing process improvements.
- Collaborate with Manufacturing, Quality, and Engineering teams to resolve production issues, support operator training, and maintain compliant manufacturing operations.