Senior Process Engineer - Sterile Ops & Validation

Resilience; Olde West Chester (OH); On-site; USD 80,000 - 121,000; Full time

Benefits offered by this job

Relocation assistance

Annual bonus

401(k) match

Job summary

Resilience in West Chester, OH, is seeking a Process Engineer III for Sterile Operations to lead improvement initiatives across multiple sterile manufacturing processes. You will serve as a technical advisor, coach engineers, and collaborate with Technical Operations, Quality, and Manufacturing.

The role requires GMP expertise and hands-on experience with automation, aseptic processes, and validation. Expect on-site work with potential travel and a strong focus on continuous improvement and

Qualifications

• Demonstrated GMP experience in sterile/aseptic manufacturing environments.
• Hands-on experience across multiple technologies (mechanics, hydraulics, pneumatics, electronics, PLCs, HMI).
• Proven ability to independently lead troubleshooting and continuous improvement initiatives.

Responsibilities

• Lead process and equipment improvement across multiple sterile processes.
• Coordinate capital projects from justification to execution and validation.
• Provide validation support and author URS, FAT, IQ/OQ/PQ protocols and reports.
• Own change controls and deviation investigations, interfacing with Quality and Regulatory.

Skills

GMP experience

Technical troubleshooting

Coaching/mentoring

Project management

LEAN manufacturing

Six Sigma troubleshooting

Education

Bachelor's degree in Engineering

Tools

Programmable logic controllers

HMI

Vision systems

Autoclave/sterilization

Job description

Resilience in West Chester, OH, is seeking a Process Engineer III for Sterile Operations to lead improvement initiatives across multiple sterile manufacturing processes. You will serve as a technical advisor, coach engineers, and collaborate with Technical Operations, Quality, and Manufacturing.

The role requires GMP expertise and hands-on experience with automation, aseptic processes, and validation. Expect on-site work with potential travel and a strong focus on continuous improvement and