Job Title: Supplier Quality EngineerLocation: Remote
Duration: 12 monthsEmployment Type: ContractJob Responsibilities: 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.
Required Qualifications: 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
Pay Scale:
Anticipated hourly pay range: specific range such as ($50/Hr to $55/Hr).
Benefits:
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.
Retirement Benefits:
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.