Process Engineer III- Device Assembly

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary

The Process Engineer III - Device Assembly is a mid-level technical leader responsible for validated assembly processes supporting combination products (e.g., drug-device systems such as prefilled syringes, auto-injectors, inhalers, or related delivery platforms) within a GMP-regulated manufacturing environment.

This role leads long-term strategic projects, provides advanced technical support to Assembly Engineers, and serves as the primary technical contact for assembly-related issues. The position partners cross-functionally with Manufacturing, Quality, Validation, Regulatory, Technical Operations, and Facilities to ensure compliant, capable, and inspection-ready processes.

Position Responsibilities

Process Ownership & Technical Leadership

• Own validated device assembly processes, ensuring control of critical process parameters (CPPs), critical quality attributes (CQAs), and established centerlines.

• Maintain processes in a state of control through continued process verification and performance monitoring.

• Serve as the technical subject matter expert (SME) for device assembly.

• Lead complex troubleshooting and root cause investigations.

• Provide mentorship and technical guidance to Assembly Engineers and Operations teams.

• Provide on-call support as required.

Validation & Compliance

• Author and/or approve URS, FAT/SAT, commissioning documentation, and IQ/OQ/PQ protocols and reports.

• Lead validation and revalidation activities in accordance with FDA Process Validation lifecycle requirements.

• Initiate and lead technical investigations for deviations, non-conformances, and complaints.

• Support change control activities, ensuring proper risk assessments and validation strategies.

• Serve as technical SME during regulatory inspections and audits.

• Participate in Annual Product Reviews and periodic system reviews.

Continuous Improvement & Strategic Projects

• Lead long-term capital and process improvement initiatives focused on:

  • Yield improvement

  • Scrap and rework reduction

  • OEE optimization

  • Automation enhancements

  • Maintenance reliability

• Support new product introductions, technology transfers, and scale-up activities.

• Manage lifecycle planning for assembly equipment and tooling.

Minimum Qualifications

• Significant experience in device assembly within a GMP-regulated pharmaceutical or combination product environment.

• Experience with process validation (IQ/OQ/PQ) and lifecycle validation principles.

• Experience leading investigations, root cause analysis, and change control processes.

Preferred Qualifications

• Bachelor's degree in engineering (Mechanical, Chemical, Biomedical, Industrial, or related discipline).

• Experience supporting regulatory inspections.

• Project management experience in capital or long-term improvement initiatives.

• Lean manufacturing or Six Sigma certification.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.