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