Senior Packaging Engineer

Intellectt INC; North Haven (CT); On-site; USD 95,000 - 135,000; Full time

Job summary

Intellectt INC is seeking a Senior Packaging Engineer based in North Haven, CT (Onsite) to lead sterile medical device packaging initiatives. The role requires 4+ years of experience in packaging and validation for terminally sterilized devices, with strong knowledge of ISO 11607, FDA regulations, and process validation.

You will design, validate, and improve packaging systems, manage cross-functional activities, and collaborate with suppliers to ensure compliant, efficient packaging operations.

Qualifications

• Bachelor's degree in Packaging, Mechanical, Manufacturing Engineering, or related field.
• 4+ years of medical device packaging experience.
• Experience with sterile barrier systems and terminally sterilized devices.
• Solid knowledge of ISO 11607, FDA 21 CFR Part 820, GMP, IQ/OQ/PQ, and process validation.
• Experience with packaging materials and equipment.
• Project management experience.
• DOE/Minitab, CSV, change control, and custom equipment validation preferred.

Responsibilities

• Design and develop sterile medical device packaging per ISO 11607, ASTM, and ISTA standards.
• Execute IQ/OQ/PQ and packaging process validation activities.
• Support packaging equipment including FFS, bar sealers, and Alloyd systems.
• Develop and review validation protocols, reports, SOPs, and controlled documentation.
• Troubleshoot packaging processes/equipment and implement corrective actions.
• Manage projects, timelines, suppliers, and cross-functional activities.

Skills

Project management

Packaging engineering

IQ/OQ/PQ

Education

Bachelor's degree in Packaging/Mechanical/Manufacturing Engineering

Tools

DOE/Minitab

Job description

Exciting contract opportunity for a Senior Packaging Engineer based in North Haven, CT (Onsite) at one of our prestigious clients.

Job Summary

Seeking a Senior Packaging Engineer with 4+ years of medical device packaging and validation experience, supporting terminally sterilized medical devices.

Key Responsibilities

• Design and develop sterile medical device packaging per ISO 11607, ASTM, and ISTA standards.
• Execute IQ/OQ/PQ and packaging process validation activities.
• Support packaging equipment including FFS, bar sealers, and Alloyd systems.
• Develop and review validation protocols, reports, SOPs, and controlled documentation.
• Troubleshoot packaging processes/equipment and implement corrective actions.
• Manage projects, timelines, suppliers, and cross-functional activities.

Requirements

• Bachelor's degree in Packaging, Mechanical, Manufacturing Engineering, or related field.
• 4+ years of relevant experience in medical device packaging.
• Experience with sterile barrier systems and terminally sterilized medical devices.
• Strong knowledge of ISO 11607, FDA 21 CFR Part 820, GMP, IQ/OQ/PQ, and process validation.
• Experience with packaging materials and equipment.
• Project management experience.
• DOE/Minitab, CSV, change control, and custom equipment validation preferred.