Packaging Process Engineer

Creative Solutions Services, LLC; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Packaging Process Engineer to support a large-scale pharmaceutical manufacturing expansion. You will provide technical leadership for packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and readiness for commercial manufacturing.

The role requires close collaboration with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to optimize packaging

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Chemical/Industrial/Packaging Engineering or related field.
• 5+ years of pharmaceutical manufacturing experience, with direct packaging operations.
• Experience with automated packaging equipment in GMP environments.
• Knowledge of packaging equipment validation, startup, and process qualification.
• Familiarity with FDA cGMP, EU GMP, and packaging best practices.
• Experience with process improvements, equipment reliability, and manufacturing optimization.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, and readiness for commercial manufacturing.
• Collaborate with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to optimize packaging operations while ensuring compliance and reliability.

Skills

Pharmaceutical packaging process eng

Automated packaging line experience

Cartoners, labelers, case packers, pal

Equipment startup, commissioning, and

Packaging process optimization

Manufacturing troubleshooting

GMP-regulated manufacturing

Cross-functional collaboration

Technical documentation/engineering

Commercial manufacturing operations

Education

Bachelor's degree in Engineering or related field

Tools

MES

SAP

TrackWise

Job description

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.