Senior Packaging Engineer

Job Title: Sr. Packaging Engineer
Location: North Haven, CT
Duration: Long-Term Contract

Job Summary

Seeking a Sr. Packaging Engineer with 4+ years of experience in medical device packaging, packaging equipment, and process validation. The role focuses on designing and validating packaging systems for terminally sterilized medical devices, ensuring compliance with ISO 11607, FDA 21 CFR Part 820, ASTM/ISTA standards, and GMP requirements.

Key Responsibilities

• Design and develop packaging systems for terminally sterilized medical devices.
• Lead IQ/OQ/PQ and packaging process validation activities.
• Validate forming, sealing, and assembly processes per ISO 11607-2.
• Support and qualify high-volume packaging equipment, including FFS, bar sealers, and Alloyd.
• Prepare and approve validation protocols, reports, SOPs, work instructions, and controlled documentation.
• Develop and improve manufacturing and packaging processes for quality, efficiency, and compliance.
• Perform process characterization, failure analysis, and process improvement activities.
• Support DOE/Minitab, SPC, equipment validation, and CSV activities.
• Ensure processes comply with FDA 21 CFR Part 820, GMP, ISO, ASTM, and ISTA requirements.
• Manage project deliverables, timelines, risks, and cross-functional execution.
• Collaborate with Quality, Regulatory, Manufacturing, Automation, Assembly, and Process Engineering teams.
• Provide technical guidance and support to engineering teams.

Required Skills

• Medical device packaging
• Packaging materials and sterile barrier systems
• Packaging equipment FFS, bar sealer, Alloyd
• IQ/OQ/PQ and process validation
• ISO 11607-1 & ISO 11607-2
• FDA 21 CFR Part 820 / GMP
• ASTM & ISTA packaging standards
• Packaging process development and characterization
• Equipment qualification and validation
• SOP and controlled documentation development
• Project management and cross-functional coordination
• DOE / Minitab preferred
• Computer System Validation (CSV) preferred
• Medical device change control preferred

Education & Experience

• Bachelor's degree in Packaging, Mechanical, Manufacturing Engineering, or related engineering field.
• 4+ years of relevant engineering experience; advanced degree with 2+ years may be considered.
• Strong preference for candidates with medical device packaging and validation experience.