Hello,
I hope you're doing well.
My name is Purna, and I'm reaching out from Intellectt Inc. regarding an exciting opportunity for a Sr. 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
.
Title: Sr. Packaging Engineer
Location: North Haven, CT
Job Summary
- We are seeking a Sr. Packaging Engineer with experience in medical device packaging and validation to support the development, qualification, and continuous improvement of packaging systems for terminally sterilized medical devices. The ideal candidate will have expertise in packaging design, process validation, regulatory compliance, and packaging equipment support.
Key Responsibilities
- Design and develop sterile packaging systems for medical devices in accordance with ISO 11607, ASTM, and ISTA standards.
- Execute packaging and equipment validation activities, including IQ, OQ, and PQ protocols.
- Support packaging operations and high-volume packaging equipment.
- Develop and review validation protocols, reports, SOPs, work instructions, and controlled documentation.
- Investigate packaging process issues and implement corrective actions to improve performance and reliability.
- Manage project timelines, deliverables, suppliers, and cross-functional activities.
- Ensure compliance with applicable quality, regulatory, and manufacturing requirements.
Required Qualifications
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field.
- 4+ years of experience in medical device packaging and validation.
- Strong knowledge of packaging materials, sterile barrier systems, and terminally sterilized medical devices.
- Experience with ISO 11607, FDA 21 CFR Part 820, GMP, IQ/OQ/PQ, and process validation.
- Strong project management, communication, and problem-solving skills.
Preferred Qualifications
- Experience with DOE, Minitab, CSV, change control, and custom equipment validation.
- Familiarity with high-volume packaging equipment and manufacturing processes.
Thanks & Regards,
Purnasree.U
Recruiter
Intellectt Inc
Purnasree.u@intellectt.com
Desk number: 7324568346 EXT: 234