Senior Packaging Engineer

Katalyst CRO; Madison (WI); On-site; USD 70,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking a Packaging Engineer to support and improve packaging operations for medical device manufacturing in Madison, WI. You will lead packaging process development, qualification, and validation activities (IQ/OQ/PQ), while collaborating across Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve issues and implement improvements.

The role requires a Bachelor's in Packaging Engineering or related field, experience in regulated manufacturing, and knowledge

Qualifications

• Knowledge of packaging validation, manufacturing processes, quality systems and regulatory requirements.
• Engineering discipline with experience in regulated environments.

Responsibilities

• Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
• Collaborate with manufacturing, quality, regulatory, operations, and engineering teams to resolve issues and drive improvements.
• Perform root cause investigations, develop CAPA solutions, and support Lean and Six Sigma initiatives.

Skills

Packaging engineering

Lean manufacturing

Six Sigma

Regulatory compliance

Education

Bachelor's Degree in Packaging Engineering/Mechanical Engineering

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.