Senior Process Engineer, Sterile Operations

Resilience; Olde West Chester (OH); Vor Ort; USD 73.000 - 121.000; Vollzeit

Benefits dieser Stelle

Annual bonus

401(k) matching

Health insurance

Paid vacation

Tuition reimbursement

Caregiving support

Zusammenfassung

Resilience is a technology-focused biomanufacturing company redefining how medicine is made. The Process Engineer III, Sterile Operations leads improvement initiatives across multiple sterile processes and serves as the escalation point for complex issues.

Collaborates with Technical Operations, Quality, Manufacturing, and Facilities to deliver GMP-compliant solutions. This role calls for strong technical ownership, coaching of junior engineers, and a focus on validation, change control, and

Qualifikationen

• GMP experience in a sterile or aseptic manufacturing environment.
• Hands-on experience across multiple technologies such as automation, hydraulics, pneumatics, and related systems.
• Proficiency in at least one discipline: automation/controls, aseptic fill-finish equipment, sterile processes, maintenance, or validation.
• Ability to independently lead technical troubleshooting and continuous improvement across multiple processes.
• Ability to coach and mentor peers on GMP practices.
• Ability to escalate complex technical issues beyond the scope of less experienced engineers.

Aufgaben

• Lead process and equipment improvement across multiple sterile processes.
• Coordinate changeover reductions, yield improvements, OEE, maintenance reliability, and waste reduction.
• Support asset data, capabilities, utilization, and supplier relationships; manage asset life cycles.
• Lead capital and process improvement projects with justification and capital planning input.
• Provide validation, qualification protocols and change control documents.
• On-call support as required.

Kenntnisse

GMP experience

Sterile manufacturing

Automation/Controls

Validation

Troubleshooting

Coaching/mentoring

Regulatory compliance

Ausbildung

Bachelor’s degree in Engineering or related science

Tools

PLC

HMI

Vision systems

Jobbeschreibung

Resilience is a technology-focused biomanufacturing company redefining how medicine is made. The Process Engineer III, Sterile Operations leads improvement initiatives across multiple sterile processes and serves as the escalation point for complex issues.

Collaborates with Technical Operations, Quality, Manufacturing, and Facilities to deliver GMP-compliant solutions. This role calls for strong technical ownership, coaching of junior engineers, and a focus on validation, change control, and