API Manufacturing Engineer — Process & Scale-Up Lead

Novozen Healthcare LLC; Sacramento (CA); Presencial; USD 62.000 - 66.000; Tempo integral

Benefícios oferecidos por esta vaga

Health insurance

401(k) retirement plan (no employer-m 

No PTO beyond state/local laws

Resumo da vaga

Novozen Healthcare LLC is seeking a Manufacturing Engineer to support API manufacturing operations under a 12-month contract. You will apply process engineering expertise to scale up production, optimize equipment startups, and troubleshoot complex manufacturing issues.

You’ll develop GMP-compliant batch records and work instructions, lead process improvements to reduce downtime and cycle times, and collaborate with cross-functional teams to ensure safety, quality, and efficiency.

Qualificações

• 5+ years in Process Engineering or API manufacturing.
• Strong chemical engineering background with hands-on manufacturing.
• Experience with GMP process troubleshooting and equipment startup.

Responsabilidades

• Provide technical engineering support for API manufacturing operations, including scale-up, startup, troubleshooting, and optimization.
• Develop and revise batch records, work instructions, cleaning procedures, and GMP documentation.
• Lead process improvement to reduce downtime, improve cycle times, and enhance safety, quality, and productivity.
• Support equipment setup, qualification, changeovers, and process improvements.
• Troubleshoot manufacturing and equipment issues with cross-functional teams.
• Support operator training and ensure GMP, safety, and quality compliance.
• Lead technical investigations and independently manage engineering activities.

Conhecimentos

Process engineering

API manufacturing

GMP troubleshooting

Equipment startup

Documentation

Formação

Chemical engineering degree

Ferramentas

Reactors

Centrifuges

Dryers

Mills

Descrição da vaga

Novozen Healthcare LLC is seeking a Manufacturing Engineer to support API manufacturing operations under a 12-month contract. You will apply process engineering expertise to scale up production, optimize equipment startups, and troubleshoot complex manufacturing issues.

You’ll develop GMP-compliant batch records and work instructions, lead process improvements to reduce downtime and cycle times, and collaborate with cross-functional teams to ensure safety, quality, and efficiency.