Sterile Packaging Lead: Compliance, Validation & Strategy

Red Star Contract Manufacturing, Inc.; Larwill (IN); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

401(k) with company match

Bonus opportunities

Job summary

Red Star Contract Manufacturing, Inc. in Indiana is seeking a Sterile Packaging Manager to lead sterile packaging strategies from concept through commercialization and post-market support.

You will partner with Regulatory, Product Development, Operations, Supply Chain, and Quality to ensure sterility, packaging integrity, shelf life, and regulatory compliance across products. You will oversee design transfer, validation strategies, and documentation (DHF) while driving continuous improvement and

Qualifications

• Bachelor's degree in Packaging Engineering, Packaging Science, Engineering, or related technical discipline.
• Minimum 5-7 years of progressive experience in sterile packaging within medical device, pharmaceutical, or related regulated industry; medical device experience strongly preferred.
• Previous experience leading projects, initiatives, teams, or direct reports preferred.

Responsibilities

• Lead strategy, development, implementation, and lifecycle management of sterile packaging designs across product lines with product development teams.
• Coordinate sterilization requirements for new products, design changes, and sustaining engineering initiatives.
• Oversee design, evaluation, and approval of packaging components and sterile systems for medical devices.

Skills

Leadership

Project management

Cross-functional collaboration

ISO 11607 knowledge

Risk management

Packaging validation

Statistical analysis

Education

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

Job description

Red Star Contract Manufacturing, Inc. in Indiana is seeking a Sterile Packaging Manager to lead sterile packaging strategies from concept through commercialization and post-market support.

You will partner with Regulatory, Product Development, Operations, Supply Chain, and Quality to ensure sterility, packaging integrity, shelf life, and regulatory compliance across products. You will oversee design transfer, validation strategies, and documentation (DHF) while driving continuous improvement and