What are the responsibilities and job description for the Packaging Engineer position at IZiel Healthcare?
Role: Packaging Engineer Level-II
Experience Required: 3 to 4 years
Location: North Haven, CT
Engagement: Fulltime
Company Description:
IZiel Healthcare is an Engineering, Software, and Regulatory Services provider supporting global medical device manufacturers from offices in the USA and India. The organization’s engineers are trained to Design for Six Sigma Black Belt standards and have delivered projects across design, process validation, quality management system documentation, regulatory approvals, and acquisition integration for Class I, IIa, IIb, and III products.
Role summary
IZiel seeks a packaging engineer to support defined Project Odyssey engineering work packages associated with the installation, relocation, commissioning, process development and validation of manufacturing equipment. The role will work with Client stakeholders and IZiel’s broader engineering team. Specific work packages will be assigned according to project priorities and the candidate’s capabilities.
Project responsibilities
- Support packaging process development and validation for automated and manual sealers, leak testing, printing and labeling equipment.
- Coordinate packaging testing, equipment troubleshooting and commissioning activities
- Develop or execute applicable IQ/OQ/PQ, TMV and process studies
- Prepare packaging-related SOPs, PFMEAs and validation documentation
Technical qualifications
- Manufacturing process and packaging design
- Packaging process development and statistical analysis
- Strong knowledge of Packaging Validation and Process Validation
- Demonstrated experience executing PDR, IQ, OQ, PQ, TMV, and packaging validation activities.
- Packaging equipment troubleshooting, including FFS/Sencorp bar sealers, and packaging testing coordination
- QMS/new equipment validation; PDR, IQ, OQ and PQ; DFA, PFMEA and MSA
Education
- Packaging Engineering or equivalent technical degree.
Preferred experience
- Direct experience with packaging equipment and process validation in a regulated manufacturing setting; familiarity with sealing and package-integrity testing is valuable.
Salary : $85,000 - $95,000