Senior Packaging Engineer Katalyst Healthcares & Life Sciences - 4.0 North Haven, CT Job Details Contract 1 day ago Qualifications Technical engineering Regulatory compliance Project management experience in manufacturing Bachelor's degree in engineering Production validation processes Leading team collaboration initiatives Biomedical regulatory compliance Cross-functional communication

Full Job Description Responsibilities:

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.

Requirements:

Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline. 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.