Packaging Process Engineer

Responsibilities

Supports technical leadership for pharmaceutical packaging operations, including:

• Equipment implementation, commissioning, qualification, and process optimization
• Ensuring equipment reliability, regulatory compliance, and efficient production performance
• Optimizing packaging 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 experience
• Experience with equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)
• Experience with packaging process optimization and continuous improvement
• Manufacturing troubleshooting and root cause investigations experience
• GMP-regulated pharmaceutical manufacturing experience
• Cross-functional collaboration with Manufacturing, Validation, Automation, and Quality experience
• Technical documentation, engineering studies, and protocol development experience
• Experience supporting commercial manufacturing operations