API Process Engineer — Scale-Up & GMP Manufacturing

Katalyst-Healthcares-; 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

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.