Senior Packaging Engineer

Katalyst CRO; North Haven (CT); On-site; USD 70,000 - 110,000; Full time

Job summary

Katalyst CRO in North Haven, CT seeks a Packaging Engineer to lead development and qualification of packaging for medical devices. You will partner with Manufacturing, Quality, Regulatory and Engineering to drive improvements and ensure FDA compliance.

Join a cross-functional team focused on Lean/Six Sigma driven optimization and robust process validation in a regulated manufacturing environment.

Qualifications

• Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related engineering discipline.
• Experience in regulated manufacturing environments (medical device, healthcare, pharmaceutical) preferred.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.

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 drive improvements.
• Perform root cause investigations and develop CAPA solutions; drive operational excellence using Lean and Six Sigma methodologies.

Skills

Lean Manufacturing

Six Sigma

Root Cause Analysis

Project Leadership

Technical Communication

Cross-functional Collaboration

Education

Bachelor's Degree in Packaging Engineering/Packaging Science 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.