Process Engineer III - Packaging

Resilience; Olde West Chester (OH); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Annual cash bonus program

401(k) plan with company match

Robust healthcare benefits

Job summary

Resilience in Olde West Chester, Ohio, is hiring a Process Engineer III – Packaging to lead technical initiatives for pharmaceutical-device systems in a GMP environment. You'll own validated packaging processes, ensure compliance, and drive continuous improvement projects.

Ideal candidates have a Bachelor's degree in engineering and significant experience in automated packaging and process validation. The role offers a robust benefits package, including healthcare, a cash bonus program, and 401(k) matching.

Qualifications

• Significant experience in pharmaceutical or combination product packaging within a GMP-regulated environment.
• Experience with automated packaging equipment and line integration.
• Experience with process validation (IQ/OQ/PQ) and lifecycle validation principles.

Responsibilities

• Own validated primary and secondary packaging processes.
• Serve as the technical subject matter expert for automated packaging lines.
• Lead long-term capital and packaging line improvement initiatives.

Skills

Pharmaceutical packaging experience

Automated packaging equipment knowledge

Root cause analysis

Change control processes

Education

Bachelor’s degree in engineering or related discipline

Tools

GMP regulations

Serialization systems

Job description

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, 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.

Position Summary

The Process Engineer III – Packaging is a technical leader responsible for validated packaging processes supporting combination products and pharmaceutical-device systems within a GMP-regulated manufacturing environment. This role leads the long-term strategic packaging initiatives and provides advanced technical support to Packaging Engineers and Operations. The position serves as the primary technical contact for packaging-related issues and partners cross‑functionally with Manufacturing, Quality, Validation, Regulatory, Technical Operations, Supply Chain, and Facilities to ensure compliant, efficient, and inspection‑ready packaging processes.

Key Responsibilities

• Process Ownership & Technical Leadership – Own validated primary and secondary packaging processes, including serialization and aggregation systems where applicable; ensure control of critical process parameters, critical quality attributes, and established operating ranges; maintain packaging processes in a state of control through continued process verification and performance monitoring.
• Serve as the technical subject matter expert for automated and semi-automated packaging lines (cartoning, labeling, blistering, pouching, case packing, serialization systems, etc.). Lead complex troubleshooting and root cause investigations for packaging deviations and line performance issues.
• Provide mentorship and technical guidance to Packaging Engineers and Operations teams; provide on‑call support as required.
• Validation & Compliance – Author and/or approve URS, FAT/SAT documentation, commissioning plans, and IQ/OQ/PQ protocols and reports for packaging equipment; lead packaging process validation and revalidation activities; initiate and lead investigations related to deviations, non‑conformances, serialization discrepancies, and packaging complaints.
• Support and manage change control activities, ensuring appropriate risk assessments and validation strategies; serve as technical SME during regulatory inspections and audits.
• Continuous Improvement & Strategic Projects – Lead long‑term capital and packaging line improvement initiatives focused on OEE optimization, yield improvement, scrap and material waste reduction, change‑over time reduction, serialization and aggregation efficiency, and line reliability and uptime improvement.
• Support new product introductions (NPI), artwork updates, and packaging component changes; manage lifecycle planning and obsolescence strategies for packaging equipment and serialization systems; support technology transfers and line expansions.
• Cross‑Functional Collaboration – Partner with Quality, Regulatory Affairs, Serialization/IT teams, Supply Chain, Manufacturing, and Facilities; collaborate with packaging material suppliers and equipment vendors to resolve technical issues and enhance material compatibility and machine performance; provide technical input for packaging component specifications and supplier qualifications; support capital procurement and supplier FAT activities.

Minimum Qualifications

• Significant experience in pharmaceutical or combination product packaging within a GMP-regulated environment.
• Experience with automated packaging equipment and line integration.
• Experience with process validation (IQ/OQ/PQ) and lifecycle validation principles.
• Demonstrated experience leading investigations, root cause analysis, and change control processes.

Preferred Qualifications

• Bachelor’s degree in engineering (Mechanical, Chemical, Industrial, Biomedical, or related discipline).
• Experience with serialization and aggregation systems.
• Experience supporting regulatory inspections.
• Project management experience in capital equipment 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.

Equal Employment Opportunity

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.

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 a benefits package 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.