Sr Packaging Engineer

Katalyst-Healthcares-; North Haven (CT); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst-Healthcares- seeks a Senior Packaging Engineer to lead packaging operations for medical device manufacturing. The role focuses on process development, equipment qualification, and validation in a regulated environment.

You will collaborate with cross-functional teams to resolve production issues, drive continuous improvement, and ensure adherence to FDA and quality systems. Strong problem-solving and leadership skills are essential.

Qualifications

• Bachelor's degree in packaging or related engineering field.
• Experience in medical device packaging is preferred.
• Knowledge of FDA regulations and quality systems.

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.
• Conduct root cause investigations and develop 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.

Skills

Packaging engineering

Regulatory knowledge

Lean Six Sigma

Education

Bachelor's degree in Packaging Engineering or related

Job description

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

• 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.