Job Description & Skill Requirement:
Responsible for supporting and improving packaging operations for medical device manufacturing.
Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA and quality system requirements.
Perform root cause investigations, develop CAPA solutions, maintain technical documentation, support packaging equipment and process validation, and drive operational excellence using Lean Manufacturing and Six Sigma methodologies.
Strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills are required.
Qualification:
Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
7+ years of Packaging Engineering experience (or equivalent advanced degree and relevant experience).
Experience in Medical Device, Healthcare, Pharmaceutical, or other regulated manufacturing environments preferred.
Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
Benefits: This a contract position does not include employer-provided benefits.
Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:
Background checks may be conducted in accordance with applicable law.
Work Authorization:
Applicants must be authorized to work in the United States
| Location | North Haven, CT |
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