Job Description

Sr. Packaging Engineer, Manufacturing Sciences at Exact Sciences summary:

The Senior Packaging Engineer at Exact Sciences leads the design and development of packaging for new and existing products, ensuring compliance with industry standards and regulations. This role manages packaging validation programs, drives process improvements, and collaborates with internal and external stakeholders to maintain quality and cost-effectiveness. Additionally, the engineer mentors junior staff and supports sustainability initiatives within packaging manufacturing in FDA-regulated and ISO13485 environments.

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Position Overview

The Senior Packaging Engineer, Manufacturing Sciences role will lead design and development of packaging for commercialization of new Exact Sciences’ products through the design transfer process, as well as manage changes to existing products. This role will be responsible for creating and maintaining the packaging design and packaging validation programs, utilized across Exact Sciences locations, compliant with packaging laws, industry-recognized standards and test methods (ASTM, ISTA, ISO, USP, etc.). This role will support implementation of existing and novel packaging test methods, as well as establish requirements and specifications to ensure product effectiveness and customer satisfaction.

Essential Duties

Include, but are not limited to, the following:

• Packaging Design - Lead packaging strategy on projects, working with internal and external stakeholders to develop packaging designs, materials, and processes for new products.
• Packaging Testing - Apply expertise in testing, validation, packaging laws, industry-recognized standards and test methods (e.g., ASTM, ISTA, ISO, USP), regulations (e.g., ISO 11607, 21 CFR 820), and risk management to identify and recommend design improvements that address deficiencies.
• Process Improvement/Cost Reduction - Drive improvements across product lines and contribute to cross-site efficiency or cost-reduction initiatives. Monitor available technologies in packaging materials and processes to identify and implement opportunities for improvement. Work with vendors and outside resources in the continuous improvement of packaging materials and processes.
• Packaging Documentation and Quality - Ensure quality and compliance of all packaging materials through specifications, validation, and root cause analysis. Author and improve Quality System documentation and lead corrective actions, change control, and risk mitigation in collaboration with Quality Engineering.
• Leadership - Mentor junior engineers and provide technical guidance,. Lead packaging phases of projects.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.

Minimum Qualifications

• Bachelor’s degree in Packaging Engineering or a relevant field as outlined in the essential duties. Bachelor's degree in Engineering, Logistics, or Supply Chain will be accepted provided a certificate in packaging engineering has been obtained.
• 5 years of experience in packaging design and/or packaging manufacturing within FDA regulated and/or ISO13485 environments.
• 2 years of experience in injection molding or thermoforming processes for primary containers and/or packaging materials.
• 2 years of experience working within SAP or other ERP systems
• Experience with CAD tools such as ArtiosCAD, Solidworks, or equivalent.

Preferred Qualifications

• 2 years of experience designing and implementing packaging solutions for medical devices compliant with international and dangerous goods standards.
• Experience leading validation efforts, including protocol development and approval of IQ/OQ/PQ reports.
• Experience leading packaging-focused sustainability initiatives.

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Salary Range:

$89,000.00 - $151,000.00

 

The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.

Keywords:

packaging engineer, packaging design, manufacturing sciences, FDA regulated, ISO13485, packaging validation, quality systems, injection molding, medical device packaging, process improvement

Job Tags

For contractors, Full time, Local area,

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