Lead Sterile Packaging Engineer – Medical Devices

Red Star Contract Manufacturing, Inc.; Larwill (IN); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Bonus opportunities

Job summary

Red Star Contract Manufacturing, Inc. is seeking a Senior Sterile Packaging Engineer to lead sterile packaging strategies from concept to post‑market support.

You will ensure sterility, package integrity, shelf life, and regulatory compliance across product lines, partnering with Regulatory, Product Development, Operations, and Quality teams. The role provides technical leadership in packaging design, validation strategies, and documentation, mentoring engineers and cross‑functional staff while

Qualifications

• Bachelor’s degree in Packaging Engineering or related technical discipline.
• 3–5 years in sterile packaging within regulated industries.
• Experience leading technical projects and cross-functional teams.
• Experience with sterile packaging validation and design controls.

Responsibilities

• Lead design, development, and lifecycle support of sterile packaging systems across product lines.
• Serve as technical lead for packaging activities supporting new product introductions.
• Develop and maintain packaging documentation and risk assessments.
• Lead validation activities including IQ/OQ/PQ and transit studies.

Skills

Sterile packaging

Project leadership

Cross-functional teamwork

Regulatory compliance

Education

Bachelor's degree in Packaging Engineering

Related technical discipline

Job description

Red Star Contract Manufacturing, Inc. is seeking a Senior Sterile Packaging Engineer to lead sterile packaging strategies from concept to post‑market support.

You will ensure sterility, package integrity, shelf life, and regulatory compliance across product lines, partnering with Regulatory, Product Development, Operations, and Quality teams. The role provides technical leadership in packaging design, validation strategies, and documentation, mentoring engineers and cross‑functional staff while