Manufacturing Sciences and Technology (MSAT) Process Engineer (2nd/3rd Shift)
On-sitePrinceton, New Jersey, United States
Job Summary
Monitor existing products and processes while generating metrics and reports for continuous verification. Support process improvements by creating electronic batch records, investigating events, and implementing corrective and preventive actions. Perform root cause analysis to isolate issues and author change controls, technical protocols, and validation activities. Ensure proper execution of protocols aligned with life cycle management standards. Work 2nd shift (4:00pm–12:30am) or 3rd shift (12:00am–8:30am) Monday through Friday. Maintain visual acuity of 20/20 and color vision for critical tasks in a GMP environment, adhering to full cleanroom gowning requirements. Join a late-stage biotechnology team developing next-generation cell therapies to improve survival rates and reduce risks for patients with blood cancer.
Required Qualifications
- B.S. in Engineering or similar fields
- 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
- Prior experience in regulated, GMP manufacturing operations
- Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs
- Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision
- Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods
- Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom
- Any skin conditions that cause shedding must be disclosed
Desired Qualifications
- Experience in biotechnology and cell therapy manufacturing preferred
- Strong communication and problem solving skills, with a desire to improve upon established processes
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