Senior Process Engineer - Sterile Operations

Resilience; Westchester (IL); On-site; USD 80,000 - 121,000; Full time

Benefits offered by this job

Annual bonus program

401(k) with company match

Healthcare benefits

Job summary

Resilience is a technology-focused biomanufacturing company pioneering a sustainable, end-to-end manufacturing network for sterile operations. The Process Engineer III will lead improvement initiatives across multiple sterile processes, acting as a technical escalation point and collaborating with Technical Operations, Quality, Manufacturing, and Facilities.

With GMP expertise, you will drive validation, change control, and continuous improvement projects, mentoring junior engineers and

Qualifications

• GMP experience in a sterile/aseptic manufacturing environment.
• Hands-on experience across automation, controls, and related equipment.
• Ability to lead technical troubleshooting and continuous improvement across multiple processes.
• Experience coaching peers on GMP practices.
• Experience serving as escalation point for complex technical issues.

Responsibilities

• Process & Equipment Improvement: ensure single technical process with centers, CPs, and clear operating procedures; drive changeover reduction, yield, OEE, and waste reductions.
• Validation & Technical Support: ensure transfer/validation success criteria; generate URS, FAT, SAT, IQ/OQ/PQ; approve validation docs; lead troubleshoot.
• Quality Systems & Compliance: implement change controls; perform risk management; initiate deviations and investigations; author SOPs and batch records; support regulatory inspections.
• Training & Development: lead technical training; coach Process Engineer I & II on GMP practices.

Skills

GMP experience

Sterile/aseptic manufacturing

Automation/controls

Validation/protocols

Project management

Six Sigma

LEAN manufacturing

Technical troubleshooting

Mentoring/coaching

Regulatory inspections

Education

Bachelor’s degree in Engineering or related science

Job description

Resilience is a technology-focused biomanufacturing company pioneering a sustainable, end-to-end manufacturing network for sterile operations. The Process Engineer III will lead improvement initiatives across multiple sterile processes, acting as a technical escalation point and collaborating with Technical Operations, Quality, Manufacturing, and Facilities.

With GMP expertise, you will drive validation, change control, and continuous improvement projects, mentoring junior engineers and