Packaging Engineer, Manufacturing Sciences at Exact Sciences

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Packaging Engineer, Manufacturing Sciences role will lead design and development of packaging for commercialization of new products, as well as manage changes to existing products.  This position will work collaboratively with other departments and external suppliers to develop, document, test, and implement new processes and procedures as part of the design transfer process. 

Essential Duties

Include, but are not limited to, the following:

• Packaging Design - Work with internal and external stakeholders to develop packaging designs, materials, and processes for new products. Identify or design product primary packaging, secondary packaging, and distribution packaging. Work with external test labs to qualify new or revised packaging or delivery methods. Act as technical liaison to vendors in development of specifications. Travel to vendors to observe and audit production runs, processes, and specifications.
• Packaging Documentation and Quality – Accountable and responsible for the quality of all packaging materials. Develop and maintain Material Specifications for all primary, secondary, and tertiary packaging materials. Apply quality engineering, statistical analysis, and experimental design techniques to perform root cause analysis for resolution of material quality problems. Perform process capability studies, set specifications for in-process inspection or QC tests, and perform process validation studies. Support packaging process validation work, as required.
• Packaging Testing - Conduct shipping studies of products. Interpret the data generated during the testing to draw conclusions and recommend changes that might resolve deficiencies in the design. Use applicable packaging laws, guidance for industry, industry-recognized standards and test methods (ASTM, ISTA, ISO, USP, etc.)
• Process Improvement/Cost Reduction - Investigate and analyze existing manufacturing processes for on-going continuous improvement opportunities. 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. Recommend and implement new or improved packaging processes and facilities.
• Project Management – Participate in cross-functional teams to support project objectives, evaluate alternative packaging approaches, and develop detailed plans and timelines. Communicate and present project status reports to teams. Monitor project progress and work with team members to address issues.
• Support and/or lead product labeling design/content for collection kits.
• Write new and edit existing Quality System documents.  Recognize Continuous Improvement opportunities for the Quality System and leads efforts.  Responsible for generating/driving corrective actions/action plans for more complex change requests/change orders, SOPs, work instruction, receiving inspection methods, and technical summary reports.  Collaborate with Quality Engineers to mitigate enterprise level risk.
• 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.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work seated in an office environment for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day.
• Ability to lift up to 30 pounds for approximately 5% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• May perform repetitious actions using lab tools.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.

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.
• Proficient in Microsoft Office Suite.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 2 years of experience working within SAP or other ERP systems.
• 2 years of experience designing and implementing packaging solutions for medical devices compliant with international and dangerous goods standards.

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Salary Range:

$85,000.00 - $135,000.00

 

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, and is eligible to receive company stock upon hire as well as annually.

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 age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company’s affirmative action program.

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.