Manufacturing Sciences and Technology (MSAT) Process Engineer (3rd Shift)

Essential Duties & Key Responsibilities:

Performs ongoing monitoring of existing products and processes
Generate metrics and reports for process monitoring and continuous process verification
Support process improvements and changes including electronic batch record creation and modifications
Investigates process events and implements corrective and preventive actions
Provides troubleshooting support for manufacturing events, equipment performance and material issues
Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities

Minimum 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
• Experience in biotechnology and cell therapy manufacturing preferred
• Strong communication and problem solving skills, with a desire to improve upon established processes
• Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
3rd Shift:
• Monday - Friday, 12:00am - 8:30am

Physical Demands

Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.