Sr. Packaging Engineer North Haven, CT (Onsite)

Responsibilities

• Support and improve 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.

Requirements

• Strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills are required.

Qualifications

• 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.