Lead Sterile Packaging Engineer - Validation & Compliance

Red Star Contract Manufacturing, Inc.; Larwill (IN); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Paid time off and paid holidays

401(k) with company match

Bonus opportunities

Job summary

Red Star Contract Manufacturing, Inc. seeks a Senior Sterile Packaging Engineer to serve as the technical lead for sterile packaging strategies from concept to post-market support.

The role partners with Regulatory, Product Development, Operations, and Quality to ensure sterility, packaging integrity, shelf life, and regulatory compliance across product lines. The engineer will mentor staff, lead cross-functional packaging projects, and help establish best practices for sterile packaging,

Qualifications

• Bachelor's degree in Packaging Engineering, Packaging Science, Engineering, or a related technical discipline.
• 3-5 years of experience in sterile packaging within the medical device, pharmaceutical, or other regulated industry; medical device experience strongly preferred.
• Demonstrated experience leading technical projects and collaborating across cross-functional teams.
• Experience with sterile packaging validation, design controls, and regulated product development preferred.

Responsibilities

• Lead the design, development, implementation, and lifecycle support of sterile packaging systems across product lines in partnership with Product Development teams to ensure packaging, labeling, and sterilization requirements are achieved.
• Serve as the technical lead for sterile packaging activities supporting new product introductions, design changes, and sustaining engineering initiatives.
• Design, evaluate, and approve packaging components and sterile packaging systems for medical device products.
• Develop, review, approve, and maintain packaging, labeling, and related technical documentation to ensure compliance with applicable requirements.
• Lead or facilitate risk assessments related to product, packaging, sterilization, and process changes to maintain sterility assurance and package integrity.
• Develop validation strategies and execute sterile packaging validation and verification activities, including sealing validations, IQ/OQ/PQ, design of experiments, transit testing, aging studies, and ongoing process monitoring.
• Monitor, evaluate, and improve sterile packaging processes across internal and external manufacturing locations.
• Develop and maintain procedures, work instructions, technical standards, and training materials related to sterile packaging and sterilization activities.
• Prepare and provide technical oversight for protocols, reports, technical justifications, and validation documentation.
• Ensure sterile packaging validation programs remain current, effective, and compliant with customer, regulatory, and internal quality requirements.
• Support design transfer activities by defining, documenting, and optimizing critical process parameters based on process capability and risk.
• Partner with Operations to optimize sterile packaging equipment, manufacturing processes, and production readiness while providing technical consultation to customers and contract manufacturing partners.
• Lead sterile packaging projects by coordinating technical activities, priorities, and deliverables to support business objectives and product launch commitments.
• Lead or support investigations and corrective actions associated with post-market surveillance, nonconformances, and quality events related to sterile packaging.
• Represent the sterile packaging function during customer, internal, regulatory, and certification audits.
• Provide technical mentoring, coaching, and knowledge sharing to engineers and other team members, while supporting the development of cross-functional project teams.

Skills

Sterile packaging design

Regulatory compliance

Technical leadership

Cross-functional collaboration

Process validation

Risk management

Education

Bachelor's degree in Packaging Engineering

Packaging Science

Engineering or related technical discipline

Job description

Red Star Contract Manufacturing, Inc. seeks a Senior Sterile Packaging Engineer to serve as the technical lead for sterile packaging strategies from concept to post-market support.

The role partners with Regulatory, Product Development, Operations, and Quality to ensure sterility, packaging integrity, shelf life, and regulatory compliance across product lines. The engineer will mentor staff, lead cross-functional packaging projects, and help establish best practices for sterile packaging,