What are the responsibilities and job description for the Sr Packaging Engineer position at Katalyst Healthcares & Life Sciences?
Job Description:
We are looking for a Senior Packaging Engineer to support and improve packaging operations for medical device manufacturing. The candidate will lead packaging process development, equipment qualification, and validation activities while ensuring compliance with FDA and quality system requirements.
Key Responsibilities:
We are looking for a Senior Packaging Engineer to support and improve packaging operations for medical device manufacturing. The candidate will lead packaging process development, equipment qualification, and validation activities while ensuring compliance with FDA and quality system requirements.
Key Responsibilities:
- Support and improve packaging operations for medical device manufacturing.
- Lead packaging process development, equipment qualification, and validation activities, including 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.
- Conduct root cause investigations and develop Corrective and Preventive Action (CAPA) solutions.
- Maintain technical documentation and support packaging equipment and process validation.
- Drive operational excellence using Lean Manufacturing and Six Sigma methodologies.
- Demonstrate strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills.
Required Qualifications:
- Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
- 7 years of Packaging Engineering experience, or an equivalent advanced degree with relevant experience.
- Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
- Experience in medical device, healthcare, pharmaceutical, or other regulated manufacturing environments is preferred.