Relocation Offered: Lead Process Engineer, Sterile Ops

Resilience; Ohio; Hybrid; USD 80,000 - 121,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan

Health care

Family building benefits

Life and disability insurance

Paid vacation

Paid holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience in West Chester is seeking a Process Engineer III, Sterile Operations to lead optimization across sterile manufacturing processes and serve as the technical escalation point. You will collaborate with Technical Operations and Quality, as well as Engineering to ensure GMP-compliant operations.

You will drive continuous improvements, coordinate capital projects, and mentor junior engineers while ensuring robust validation, documentation, and regulatory readiness across multiple sterile

Qualifications

• Demonstrated GMP experience in a sterile or aseptic regulated manufacturing environment.
• Hands-on experience across automation, controls, aseptic fill-finish, validation, and change control.
• Proven ability to lead technical troubleshooting and continuous improvement across multiple processes.

Responsibilities

• Process & Equipment Improvement: ensure a capable sterile manufacturing process with defined parameters and procedures.
• Validation & Technical Support: generate URS, FAT, SAT, IQ/OQ/PQ documents and validate changes.
• Quality Systems & Compliance: manage change controls and support regulatory inspections as process owner.
• Training & Development: coach and mentor engineers on GMP practices and processes.

Skills

GMP experience

Sterile aseptic

Automation/Controls

Troubleshooting

Mentoring

Project leadership

Education

Bachelor’s degree in Engineering

Tools

PLC/SCADA

HMI systems

Validation protocols

Job description

Resilience in West Chester is seeking a Process Engineer III, Sterile Operations to lead optimization across sterile manufacturing processes and serve as the technical escalation point. You will collaborate with Technical Operations and Quality, as well as Engineering to ensure GMP-compliant operations.

You will drive continuous improvements, coordinate capital projects, and mentor junior engineers while ensuring robust validation, documentation, and regulatory readiness across multiple sterile