Senior Packaging Engineer

Job Description

We are seeking an experienced Packaging Validation Engineer to support the design, development, validation, and continuous improvement of packaging systems for terminally sterilized medical devices. The ideal candidate will have strong expertise in medical device packaging, equipment qualification, process validation, and regulatory compliance while collaborating with cross-functional teams to ensure high-quality, compliant manufacturing processes.

Key Skills

• Medical packaging materials and packaging equipment (FFS, Bar Sealer, Alloyd)
• Packaging system design and development per ISO 11607-1
• Process validation including IQ, OQ, PQ and Process Validation Lifecycle
• Equipment qualification and validation documentation
• ASTM and ISTA packaging standards
• FDA 21 CFR Part 820 Quality System Regulations and Medical Device GMP
• Manufacturing process development and statistical process control
• Project management, project planning, and execution
• Manufacturing documentation, SOP development, and change control
• Cross-functional collaboration with Manufacturing, Quality, Regulatory, and Engineering

Required Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related Engineering discipline
• Experience with medical device packaging validation and terminally sterilized products
• Strong knowledge of ISO 11607-1 and ISO 11607-2 requirements
• Experience performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Experience developing and reviewing validation protocols, reports, and controlled documentation
• Knowledge of manufacturing process design, equipment qualification, and failure analysis
• Experience leading projects, timelines, and technical deliverables

Additional Skills

• DOE (Design of Experiments) using Minitab
• Computer System Validation (CSV)
• Custom equipment validation
• SOP development
• Medical device change control
• Statistical Process Control (SPC)
• Documentation management and GMP compliance
• Strong communication and stakeholder management skills