Senior Packaging Engineer

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, and maintain technical documentation.
• Support packaging equipment and process validation.
• Drive operational excellence using Lean Manufacturing and Six Sigma methodologies.
• Apply strong problem‑solving, project leadership, technical communication, and cross‑functional collaboration skills.

Requirements

• Bachelor’s Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
• Engineering experience (or equivalent advanced degree with 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.