Manufacturing Engineer

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

Job Title: Manufacturing Engineer – API Manufacturing

Employment Type: Contract – 12 Months

Job Responsibilities

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

Required Qualifications

• 5+ years of experience in Process Engineering or API manufacturing.
• Strong chemical engineering background with hands-on manufacturing experience.
• Experience with GMP process troubleshooting, process optimization, and equipment startup.
• Knowledge of manufacturing equipment such as reactors, centrifuges, dryers, and mills.
• Experience with technical documentation, batch records, and process safety.

Preferred Qualifications:

• Experience with PHA/PSSR and CAPA investigations.
• Knowledge of equipment qualification and P&IDs.
• Experience with mass balance and emission calculations.

Pay Scale

Anticipated hourly pay range $45–$48 per hour on W2.

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):

No PTO other than that required by applicable state and local laws.