Packaging Process Engineer

Katalyst CRO; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks an experienced Packaging Process Engineer to lead packaging operations for a large-scale pharmaceutical manufacturing expansion in Raleigh, NC. This consultant role focuses on technical leadership, equipment implementation, commissioning, qualification, and continuous process optimization to enable commercial readiness.

You will collaborate with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering to ensure GMP compliance, equipment

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• 0

Responsibilities

• Provide technical leadership for pharmaceutical packaging operations.
• Support equipment implementation, commissioning, qualification, and optimization.
• Collaborate with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering.
• Ensure equipment reliability, regulatory compliance, and production efficiency.
• Support packaging lines from startup through commercial operations.

Skills

Packaging engineering

Automated packaging

Commissioning IQOQ

GMP experience

Regulatory compliance

Cross-functional collaboration

Troubleshooting

Technical writing

Serialization

Education

Bachelor's degree in Mechanical/related engineering

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.