Night Shift Process Engineer II – GMP Biomanufacturing

Resilience; Kentucky; Hybrid; USD 70,000 - 96,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Healthcare (medical, dental, vision)

Paid vacation and holidays

Tuition reimbursement

Job summary

Resilience is a science-driven biomanufacturing company seeking a Process Engineer II for night shift operations in West Chester, OH. The role focuses on maintaining a single, capable process with clear centerlines, parameters, and procedures while driving continuous improvements.

The position requires diverse engineering skills across automation, aseptic packaging, validation, and change control, with Lean and Six Sigma experience highly valued.

Qualifications

• Bachelor’s degree in engineering or related science required or preferred.
• Experience in GMP or regulated production environment preferred.
• Experience with Six Sigma and analytical troubleshooting desirable.
• LEAN manufacturing experience and project management skills beneficial.

Responsibilities

• Lead continuous process improvement efforts: changeover reduction, yield improvements, OEE, maintenance reliability, waste reduction for automated pharmaceutical manufacturing equipment.
• Ensure success criteria for technology transfer and validation; verify the process is capable for merge into Manufacturing/Facility processes.
• Generate URS, FAT, SAT, commissioning, IQ/OQ/PQ protocols and reports; manage equipment data and lifecycle.
• Provide engineering and project management services; support technical training for Operations/Engineering/Maintenance.
• Perform routine validation and periodic reviews; lead technical troubleshooting and on-call support as required.

Skills

Automation/ controls

Aseptic/Packaging equipment

Process validation

Change control

Six Sigma/analytical trouble shooting

Lean manufacturing

Mech/Hydraulic/Pneumatic systems

Electrical/PLC/HMI

GMP experience

Education

Bachelor’s degree in engineering or related science

Job description

Resilience is a science-driven biomanufacturing company seeking a Process Engineer II for night shift operations in West Chester, OH. The role focuses on maintaining a single, capable process with clear centerlines, parameters, and procedures while driving continuous improvements.

The position requires diverse engineering skills across automation, aseptic packaging, validation, and change control, with Lean and Six Sigma experience highly valued.