What are the responsibilities and job description for the Senior Packaging Engineer position at Katalyst CRO?
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.
- 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.