Senior Packaging Development Engineer

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

Job summary

The Sr. Packaging Engineer at Katalyst CRO provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives.

Key duties include evaluating packaging design gaps per ISO11607, leading remediation plans, validating packaging systems, and supporting labeling and regulatory audits within a collaborative, cross-functional environment in the CT area.

Qualifications

• Bachelor's degree in engineering.
• 5+ years of medical device or pharma packaging experience.
• Validation of Packaging Systems.
• Gap Analysis.
• ISO11607.
• Ability to conduct Packaging systems Gap Analysis according to ISO11607 Part 1.
• Experience leading project meetings.

Responsibilities

• Evaluate current state of packaging design and gap analysis to ISO11607 Part 1/2.
• Generate and execute packaging remediation plans for sterile barrier systems and packaging.
• Lead validation of packaging systems for medical devices.
• Identify and develop innovative packaging processes as part of cross functional team.
• Support regulatory audits, draft technical responses and ensure compliance.
• Lead project meetings and provide updates to management.
• Assist in labeling development process.

Education

Bachelor's degree in engineering

Job description

The Sr. Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives.

Roles & Responsibilities

• Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.


• Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.


• Leads successful validation of packaging systems for medical devices


• Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.


• Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.


• Lead project meetings and provide updates to management.


• Assist in labeling development process.

Education & Experience

• Bachelor's degree in engineering


• 5+ years of medical device or pharma packaging experience


• Validation of Packaging Systems


• Gap Analysis


• ISO11607


• Ability to conduct Packaging systems Gap Analysis according to ISO11607 Part 1


• Experience leading project meetings