Packaging Process Engineer

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

Job summary

Creative Solutions Services, LLC in Raleigh, NC is seeking an experienced Packaging Process Engineer to lead packaging equipment implementation, startup, qualification, and optimization for a large pharmaceutical expansion.

You will collaborate with Manufacturing, QA, Validation, Automation, and Maintenance to ensure regulatory compliance and continuous improvement across automated lines, cartoners, labelers, and palletizers.

Qualifications

• Bachelor’s degree in engineering required with 5+ years in pharma packaging.
• Experience with GMP-regulated packaging operations and validation.
• Strong troubleshooting, writing, and cross-functional collaboration.

Responsibilities

• Lead technical activities for packaging equipment implementation, startup, qualification, and optimization.
• Collaborate with Manufacturing, QA, Validation, Automation, and Maintenance to ensure readiness.
• Support commercial manufacturing readiness and continuous improvement initiatives.

Skills

Pharma packaging

Automated packaging lines

Cartoners

Labelers

Case packers

Palletizers

FAT/SAT/IQ/OQ

GMP compliance

Cross-functional collaboration

Technical writing

Regulatory knowledge

Education

Bachelor's degree in Mechanical / Manufacturing / Chemical Engineering

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.