Process Engineer II; Pharmaceutical Manufacturing

Position: Process Engineer II (Pharmaceutical Manufacturing)
Pay Rate Low: 90000 | Pay Rate High: 115000

Our client is a global biopharmaceutical company seeking a Process Engineer II to support commercial and clinical pharmaceutical manuacturing, with a focus on oral solid dosage (OSD) products.

Title: Process Engineer II (Pharmaceutical Manufacturing)
Salary: $90-115K +Bonus
Hours: 1st shift ~8am-5pm M-F
Location:
Onsite in Wilmington, OH (Excellent Relocation assistance provided if needed!)
Summary

The Process Engineer supports commercial and clinical pharmaceutical manufacturing, with a focus on oral solid dosage (OSD) products. This role is responsible for process scaleup and transfer, equipment selection and commissioning, and continuous improvement of manufacturing and packaging operations.

Essential Functions

• Troubleshoot and maintain manufacturing systems, processes, and equipment.
• Support the development or transfer of manufacturing and cleaning processes for the manufacturing area.
• "Hands-on" ability to install and troubleshoot instrumentation and equipment.
• Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
• Specify and size manufacturing systems, equipment, and process equipment.

Basic Qualifications:

• BS degree in Engineering or technical discipline.
• 2-5 year of manufacturing experience or technical experience.

Preferred Qualification:

• 2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience.
• Experience with OSD equipment procurement.
• Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
• Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up.
• Knowledge of OSD pharmaceutical process and equipment validations.
• Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc
• MUST be authorized to work in the US without sponsorship

Physical Demands

• Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time
• Ability to lift/move 40 lbs. overhead. Ability to team lift up to 100 lbs.
• Must be able to be medically cleared for respirator use (PAPR)
• Ability to operate different types of production equipment.
• Ability to gown correctly for clean room manufacturing operations.
• Ability to stand or sit for extended periods (up to 2 hours at a time).
• Must be able to work in an office and a manufacturing environment.

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