Biomedicine, Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, Documentation, Engineering, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Medical Equipment, Process Improvement, Process Validation, Product Packaging, Product Support, Product/Service Launch, Project/Program Management, Regulatory Compliance, Research & Development (R&D), Root Cause Analysis, Statistics, Technical Writing, Testing
Hello,
I hope you're doing well.
My name is Purna, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for aSenior Packaging Engineer based in North Haven, CT (Onsite)with 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
purnasree.u@intellectt.com
.Role: Senior Packaging Engineer
Location: North Haven, CT (Onsite)
Job Summary
Seeking a Sr. Packaging Engineer with experience in medical device packaging development, package validation, and regulatory compliance. The ideal candidate will support packaging design, validation, process improvements, and new product launches while ensuring compliance with FDA and ISO standards.
Key Responsibilities
- Design and develop packaging solutions for medical devices.
- Execute packaging validation activities including IQ, OQ, PQ, TMV, and transportation testing.
- Develop packaging specifications, protocols, and technical documentation.
- Perform package testing such as seal integrity, burst, peel, transit, and aging studies.
- Support process improvements, root cause investigations, and CAPA activities.
- Collaborate with R&D, Manufacturing, Quality, and Suppliers.
- Ensure compliance with FDA, ISO 11607, and ISO 13485 requirements.
Required Qualifications
- Bachelor's degree in Packaging, Mechanical, Biomedical, or related Engineering discipline.
- 4+ years of packaging engineering experience.
- Experience with medical device packaging validation.
- Knowledge of IQ/OQ/PQ, TMV, packaging testing, and statistical analysis.
- Strong documentation and project management skills.
Preferred Qualifications
- Experience with sterile barrier systems.
- Knowledge of ISO 11607, ASTM, ISTA, FDA 21 CFR Part 820, and EU MDR.
- Experience supporting new product introductions (NPI).
Thanks & Regards,
Purnasree.U
Recruiter
Intellectt Inc
Purnasree.u@intellectt.com
Desk number: 7324568346 EXT: 234