Process Engineer III - Packaging
Job in
West Chester Township, Butler County, Ohio, 45071, USA
Listed on 2026-06-02
Listing for:
Resilience
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer, Packaging Engineer -
Manufacturing / Production
Quality Engineering, Manufacturing Engineer, Packaging Engineer
Job Description & How to Apply Below
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
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 (CPPs), critical quality attributes (CQAs), 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 (SME) 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
* Changeover time reduction
* Serialization and aggregation efficiency
* 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…
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