Senior Medical Packaging Engineer - Process & Validation

Katalyst-Healthcares-; North Haven (CT); In loco; USD 110.000 - 140.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

Packaging engineering

Regulatory knowledge

Lean Six Sigma

Formazione

Bachelor's degree in Packaging Engineering or related

Descrizione del lavoro

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.