Senior Sterile Packaging Engineer, Medical Devices

Red Star; Larwill (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Bonus opportunities

Paid time off and holidays

Job summary

Red Star is seeking a Senior Sterile Packaging Engineer to serve as the technical lead for sterile packaging activities. You will partner with Regulatory, Product Development, Operations, Supply Chain and Quality to ensure sterility, packaging integrity, shelf life, and regulatory compliance across products.

This role provides technical leadership for packaging design and validation strategies, process controls, and documentation, including DHF requirements.

Qualifications

• Bachelor's degree in Packaging Engineering, Packaging Science, Engineering, or a related discipline.
• 3-5 years of sterile packaging experience in regulated industries; medical device preferred.
• Experience leading technical projects and cross-functional collaboration.
• Experience with sterile packaging validation and design controls.

Responsibilities

• Lead sterile packaging systems design, development, and lifecycle support across product lines.
• Serve as technical lead for sterile packaging activities supporting NPI and changes.
• Design, evaluate, and approve packaging components and sterile systems.
• Develop, review, and maintain packaging documentation per requirements.
• Lead risk assessments for product, packaging, sterilization, and process changes.
• Develop validation strategies and execute IQ/OQ/PQ, aging studies, and transit tests.

Skills

Sterile packaging design

Regulatory compliance

Cross-functional collaboration

Project leadership

Design controls

ISO 11607 knowledge

Education

Bachelor's degree in Packaging Engineering/Packaging Science/Engineering or related

Tools

IQ/OQ/PQ validation

Design of Experiments (DOE)

Statistical analysis

Job description

Red Star is seeking a Senior Sterile Packaging Engineer to serve as the technical lead for sterile packaging activities. You will partner with Regulatory, Product Development, Operations, Supply Chain and Quality to ensure sterility, packaging integrity, shelf life, and regulatory compliance across products.

This role provides technical leadership for packaging design and validation strategies, process controls, and documentation, including DHF requirements.