API Process Engineer

• 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.

Key Responsibilities:

• 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.

Must Have Skills:

• 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