Senior Packaging Engineer

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Packaging Engineer based in North Haven, CT (Onsite) at one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at View email address on us.fitly.work OR View phone number on us.fitly.work







Job Title:Senior Packaging Engineer



Location: North Haven, CT

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.
  
  
  
  
  Thanks & Regards,
  Mahalakshmi
  Junior Recruiter
  Intellectt Inc
  
  
  View email address on us.fitly.work
  Direct: View phone number on us.fitly.work

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