Senior Packaging Engineer

Katalyst CRO; North Haven (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in North Haven, CT seeks a Packaging Engineer to lead packaging process development for medical devices. You will qualify equipment, support IQ/OQ/PQ validation, and drive improvements across manufacturing operations.

Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve issues, ensure compliance with FDA quality systems, and apply Lean and Six Sigma to achieve operational excellence.

Qualifications

• 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.

Responsibilities

• 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 and implement improvements.
• Perform root cause investigations, develop CAPA solutions, and support packaging equipment and process validation.

Skills

Lean Manufacturing

Six Sigma

Cross-functional collaboration

Education

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

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.