Process Engineer III - Packaging

Resilience; Port Union (OH); On-site; USD 80,000 - 121,250; Full time

Benefits offered by this job

Annual cash bonus program

401(k) plan with generous match

Comprehensive healthcare benefits

Tuition reimbursement

Job summary

A technology-focused biomanufacturing company in Ohio seeks a Process Engineer III - Packaging to lead validated packaging processes. This role demands significant experience in pharmaceutical packaging and automated equipment, ensuring compliance within a GMP-regulated setting. Additionally, you'll mentor engineers and collaborate with cross-functional teams to enhance packaging efficiency and quality. Offering a robust benefits package, the company provides competitive salaries ranging from $80,000 to $121,250 annually.

Qualifications

• Significant experience in pharmaceutical or combination product packaging within a GMP-regulated environment.
• Experience with automated packaging equipment and line integration.
• Demonstrated experience leading investigations and root cause analysis.

Responsibilities

• Own validated primary and secondary packaging processes.
• Lead packaging process validation and revalidation activities.
• Partner with quality and regulatory teams for compliance.

Skills

Pharmaceutical packaging experience

Automated packaging equipment

Root cause analysis

Change control processes

Collaboration with cross-functional teams

Education

Bachelor's degree in engineering

Tools

Serialization systems

Job description

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 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.

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. Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.