Process Engineer II (Pharmaceutical Manufacturing)

Location: West Chester, Ohio, USA. Onsite night-shift position with rotating 12-hour shifts on a 2/2/3 schedule.

Salary: $70,000–$96,250 per year.

Company

Technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for pharmaceutical production.

What you will do

• Develop and maintain capable pharmaceutical manufacturing processes with clear centerlines, critical process parameters, material requirements, and operating procedures.
• Lead continuous improvement initiatives focused on changeover reduction, yield, OEE, maintenance reliability, and waste reduction for automated equipment.
• Support technology transfer, process and equipment validation, commissioning, qualification, and periodic review activities.
• Generate and review URS, FAT, SAT, IQ/OQ/PQ, validation, change control, SOP, batch record, and investigation documentation.
• Manage equipment and asset lifecycles, supplier relationships, equipment capabilities, utilization, efficiency, and obsolescence.
• Provide technical troubleshooting, project management, training support, on-call assistance, and support for deviations, risk management, and process changes.

Requirements

• Training or experience with mechanics, hydraulics, pneumatics, vacuum technology, electronics, PLCs, HMI, computerized systems, vision systems, refrigeration, and electrical and mechanical test equipment.
• Ability to develop proficiency in automation and controls, aseptic and packaging equipment, process and materials, maintenance, and validation.
• 2–5 years of experience in a relevant engineering or manufacturing environment.
• Experience with GMP or another regulated production environment, process validation, cleaning validation, technology transfer, change control, and applied statistics.
• Bachelor’s degree in engineering or a related science is preferred.
• Work authorization or visa sponsorship is not available for this position.

Nice to have

• Project management experience.
• Six Sigma and analytical troubleshooting experience.
• Experience in a LEAN manufacturing environment.

Culture & Benefits

• Rotating 12-hour night-shift schedule with on-call support as required.
• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, vision, life, and disability insurance.
• Paid vacation, paid holidays, and other paid leave.
• Tuition reimbursement, family-building benefits, and caregiving support.