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Exact Sciences · 4 months ago

Sr. Packaging Engineer, Manufacturing Sciences

US - WI - Madison

Full-time

Onsite

Mid, Senior Level

$89K/yr - $151K/yr

5+ years exp

Exact Sciences is helping change how the world prevents, detects and guides treatment for cancer. The Senior Packaging Engineer, Manufacturing Sciences role will lead design and development of packaging for commercialization of new products and manage changes to existing products, ensuring compliance with industry standards and regulations.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

Responsibilities

Lead packaging strategy on projects, working with internal and external stakeholders to develop packaging designs, materials, and processes for new products

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

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

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

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

Qualification

Packaging DesignPackaging TestingCAD ToolsSAPERP SystemsInjection MoldingThermoforming ProcessesProcess ImprovementQuality ComplianceLeadership

Required

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

Demonstrated ability to perform the essential duties of the position with or without accommodation

Authorization to work in the United States without sponsorship