API Process Engineer

Katalyst Healthcares & Life Sciences; Sacramento (CA); Presencial; USD 90.000 - 130.000; Tempo integral

Resumo da vaga

Katalyst-Healthcares- in California is seeking an experienced Process Engineer for API manufacturing to provide technical support for regulated production operations. The role emphasizes process scale-up, equipment startup, and on‑the‑line improvements.

You will develop batch records, support qualification and investigations, and collaborate with Manufacturing, Quality, and Engineering to enhance safety, quality, and productivity.

Qualificações

• 5+ years of process engineering or API manufacturing experience.
• Hands-on GMP process troubleshooting and equipment startup experience.
• Strong background in process safety and batch documentation.

Responsabilidades

• Provide technical engineering support for process scale-up and startup; troubleshoot and optimize production processes.
• Develop and revise batch records, work instructions, cleaning procedures, and GMP-related documentation.
• Lead process improvement initiatives to reduce downtime, improve cycle times, and enhance safety, quality, and productivity.
• Collaborate with Manufacturing, Quality, and Engineering to resolve production issues and support operator training.

Conhecimentos

Process engineering

GMP troubleshooting

Equipment startup

Process optimization

Cross-functional collaboration

Formação

Bachelor's degree in Chemical Engineering

Descrição da vaga

Job Description:

• 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