What are the responsibilities and job description for the Senior Packaging Engineer position at Intellectt Inc?
Job Title: Sr. Packaging Engineer
Location: North Haven, CN
Job Summary
We are seeking an experienced Sr. Packaging Engineer to support the design, development, validation, and implementation of packaging systems for medical devices. The ideal candidate will have strong experience in medical device packaging, packaging equipment validation, and process validation (IQ/OQ/PQ) while ensuring compliance with FDA and ISO standards.
Key Responsibilities
- Design and develop packaging systems for sterile medical devices.
- Support packaging process validation, including IQ, OQ, and PQ activities.
- Work with high-volume packaging equipment such as Form Fill Seal (FFS), Bar Sealers, and Alloyd machines.
- Prepare and review validation protocols, reports, SOPs, and manufacturing documentation.
- Collaborate with Manufacturing, Quality, Regulatory, Packaging, and Process Engineering teams.
- Lead packaging-related projects, develop timelines, and ensure on-time execution.
- Perform process improvements, troubleshooting, and failure analysis.
- Ensure compliance with FDA 21 CFR Part 820, GMP, ISO 11607, and packaging validation requirements.
Required Skills
- Medical device packaging experience.
- Experience with Packaging Equipment (FFS, Bar Sealer, Alloyd).
- Strong knowledge of IQ, OQ, PQ, Process Validation, and equipment qualification.
- Experience with ISO 11607 packaging validation standards.
- Project Management skills.
- Knowledge of FDA Quality System Regulations (21 CFR Part 820) and GMP.