Process Engineer III- Device Assembly
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
Benefits
- Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
