Senior Sterile Process Engineer & Validation Lead

Resilience; Olde West Chester (OH); Vor Ort; USD 80.000 - 121.000; Vollzeit

Benefits dieser Stelle

Annual bonus program

401(k) match

Healthcare benefits

Paid vacation

Paid holidays

Zusammenfassung

Resilience, a biomanufacturing technology company in Ohio, seeks a Process Engineer III, Sterile Operations. You will lead technical improvements across sterile manufacturing, validate processes, and support regulatory readiness.

You will coach junior engineers, manage multiple projects, and collaborate with Tech Ops, Quality, and Facilities. The role requires GMP experience in aseptic environments, strong troubleshooting, and project-management skills.

Qualifikationen

• GMP experience in sterile or aseptic manufacturing environments.
• Hands-on experience across multiple technologies (mechanics, hydraulics, automation, validation).
• Proficiency in at least one discipline: automation/controls, sterile equipment, maintenance or validation.
• Ability to lead troubleshooting and continuous improvement across multiple processes.
• Ability to coach peers on GMP practices and act as escalation point for complex issues.
• Experience with project management and change control processes.

Aufgaben

• Process & Equipment Improvement across multiple sterile processes with defined centerlines and parameters.
• Lead changeover, yield, OEE, reliability, and waste-reduction initiatives for automated systems.
• Define asset data, lifecycle management, and supplier relationships for equipment.
• Lead capital and process-improvement projects with justification and planning.
• Technology transfer readiness, validation, and coordination of protocols and reports.
• Author and review validation/change-control documentation (URS, FAT, SAT, IQ/OQ/PQ).
• Perform routine validation and periodic reviews on validated processes.
• Lead troubleshooting; provide on-call support as required.
• Identify and implement change controls and risk management.
• Develop SOPs, Batch Records, and other quality documentation.
• Serve as contact for regulatory inspections as technical process owner.
• Participate in periodic product and systems reviews.

Kenntnisse

GMP experience

Troubleshooting

Coaching & mentoring

Project management

Six Sigma

LEAN manufacturing

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Engineering or related science

Jobbeschreibung

Resilience, a biomanufacturing technology company in Ohio, seeks a Process Engineer III, Sterile Operations. You will lead technical improvements across sterile manufacturing, validate processes, and support regulatory readiness.

You will coach junior engineers, manage multiple projects, and collaborate with Tech Ops, Quality, and Facilities. The role requires GMP experience in aseptic environments, strong troubleshooting, and project-management skills.