Senior Packaging Engineer, Manufacturing Sciences; part-time

W2 only, no C2C, must be authorized to work in the US (both now and in the future).

Senior Packaging Engineer, Manufacturing Sciences (part-time) (Contract) - in Madison, Wisconsin. Apply now for this opportunity at Carex!

Carex is partnering with a Bio Tech industry partner to hire a Senior Packaging Engineer, Manufacturing Sciences. This role leads the design and development of packaging solutions to support commercialization of new products through the design transfer process and manages changes to existing products. The Senior Packaging Engineer is responsible for establishing and maintaining packaging design and validation programs across multiple locations, ensuring compliance with applicable packaging laws, industry standards, and regulatory requirements.

This position plays a critical role in driving product effectiveness, regulatory compliance, operational efficiency, and customer satisfaction.

The Senior Packaging Engineer will lead packaging strategy, design, testing, validation, and continuous improvement initiatives. This role collaborates cross-functionally to develop compliant, innovative, and cost-effective packaging systems while ensuring alignment with regulatory standards including ASTM, ISTA, ISO, USP, ISO 11607, and 21 CFR 820. The position also provides technical leadership, mentors junior engineers, and drives quality and risk mitigation efforts across packaging programs.

• Lead packaging strategy for new product development projects, collaborating with internal and external stakeholders to design packaging materials, systems, and processes.
• Drive packaging design transfer activities to support commercialization.
• Apply expertise in packaging validation, regulatory standards, and risk management to recommend and implement design improvements.
• Develop and maintain packaging validation programs aligned with ASTM, ISTA, ISO, USP, ISO 11607, and 21 CFR 820 requirements.
• Implement and support both existing and novel packaging test methods.
• Establish packaging requirements and specifications to ensure product integrity and customer satisfaction.
• Identify and execute process improvements and cost-reduction initiatives across product lines and sites.
• Monitor advancements in packaging materials and technologies to drive innovation and efficiency.
• Partner with vendors and external resources to improve packaging materials and processes.
• Author and enhance Quality System documentation, including specifications, validation protocols, and reports.
• Lead root cause investigations, corrective actions, change control, and risk mitigation activities in collaboration with Quality Engineering.
• Mentor junior engineers and provide technical leadership across packaging-focused initiatives.
• Lead packaging phases of cross-functional projects.
• Support compliance with Quality Management System policies and procedures.

• Bachelor’s degree in Packaging Engineering or a related field. A Bachelor’s degree in Engineering, Logistics, or Supply Chain with a certificate in Packaging Engineering will also be considered.
• Minimum of 5 years of experience in packaging design and/or manufacturing within FDA-regulated and/or ISO 13485 environments.
• At least 2 years of experience in injection molding or thermoforming processes for primary containers and/or packaging materials.
• Minimum of 2 years of experience working with SAP or other ERP systems.
• Experience using CAD tools such as Artios
  
  CAD, Solid Works, or equivalent.
• Experience designing and implementing packaging solutions for medical devices in compliance with international and dangerous goods standards preferred.
• Experience leading validation efforts, including development and approval of IQ/OQ/PQ protocols and reports preferred.
• Experience leading packaging-focused sustainability initiatives preferred.
  
  Demonstrated ability to lead technical initiatives, drive cross-functional collaboration, and mentor team members.

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.