Packaging Process Engineer

Katalyst CRO; Durham (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced Packaging Process Engineer to support a major pharmaceutical manufacturing expansion in Durham, NC. The role encompasses technical leadership for packaging operations, equipment implementation, commissioning, qualification, process optimization, and readiness for commercial manufacture.

The ideal candidate will collaborate across Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering, ensuring equipment reliability and regulatory

Qualifications

• Bachelor-level engineering degree required in a related discipline.
• 5+ years of pharmaceutical manufacturing experience with direct packaging operations involvement.
• Experience with automated packaging equipment in GMP-regulated environments.
• Strong understanding of packaging equipment validation, startup, and qualification.
• Knowledge of FDA cGMP, EU GMP, and pharma packaging best practices.
• Experience leading process improvements and equipment reliability initiatives.
• Excellent troubleshooting, technical writing, communication, and cross-functional collaboration skills.

Responsibilities

• Provide technical leadership for pharmaceutical packaging operations during expansion.
• Support equipment implementation, commissioning, qualification, and process optimization.
• Collaborate with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to ensure reliability and regulatory compliance.

Skills

Packaging engineering

Process optimization

GMP compliance

Troubleshooting

Cross-functional collaboration

Technical writing

Documentation

Project coordination

Education

Bachelor's degree in Engineering (Mechanical/Manufacturing/Packaging)

Tools

MES

SAP

TrackWise

Job description

Seeking an experienced Packaging Process Engineer to support a large-scale pharmaceutical manufacturing expansion. This consultant will provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and commercial manufacturing readiness.

Working closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will optimize packaging operations while ensuring equipment reliability, regulatory compliance, and efficient production performance. The successful candidate will have experience supporting automated pharmaceutical packaging lines from startup through commercial operations.

Responsibilities

• Seeking an experienced Packaging Process Engineer to support a large-scale pharmaceutical manufacturing expansion. This consultant will provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and commercial manufacturing readiness.
• Working closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will optimize packaging operations while ensuring equipment reliability, regulatory compliance, and efficient production performance. The successful candidate will have experience supporting automated pharmaceutical packaging lines from startup through commercial operations.

Requirements

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Chemical Engineering, Industrial Engineering, Packaging Engineering, or a related engineering discipline.
• 5+ years of pharmaceutical manufacturing experience, with direct experience supporting packaging operations.
• Experience supporting automated packaging equipment within a GMP-regulated environment.
• Strong understanding of packaging equipment validation, manufacturing startup, and process qualification.
• Knowledge of FDA cGMP regulations, EU GMP requirements, and pharmaceutical packaging best practices.
• Experience supporting process improvements, equipment reliability initiatives, and manufacturing optimization.
• Excellent troubleshooting, technical writing, communication, and cross‑functional collaboration skills.

Preferred Qualifications

• Experience with serialization, aggregation, and track‑and‑trace systems.
• Experience supporting packaging of sterile injectable products, cartridges, syringes, or combination products.
• Familiarity with MES, SAP, TrackWise, or other manufacturing execution and quality systems.
• Lean Manufacturing and Six Sigma experience is preferred.

Most Important Skills Needed

• Pharmaceutical packaging process engineering experience
• Automated packaging line experience
• Cartoners, labelers, case packers, palletizers, and packaging equipment
• Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)
• Packaging process optimization and continuous improvement
• Manufacturing troubleshooting and root cause investigations
• GMP‑regulated pharmaceutical manufacturing
• Cross‑functional collaboration with Manufacturing, Validation, Automation, and Quality
• Technical documentation, engineering studies, and protocol development
• Experience supporting commercial manufacturing operations.