Senior Process Engineer

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At Exact Sciences, we're helpingchange 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 Senior Process Engineer will lead collaboration efforts with internal experts and external partners to procure, install, and commission equipment, utility, and process systems. This position will lead engineering support for system qualification, operation, and maintenance. Specifically, this role will be expected to set vision and provide direction to the project team and demonstrate subject matter expertise across multiple disciplines. Additionally, the Senior Process Engineer will develop requirements in support of process and process utilities and monitor performance of the supporting infrastructure. The Senior Process Engineer leads large and/or complex cross-functional initiatives with minimal guidance from leadership.

Essential Duties

Include, but are not limited to, the following:

• Conceive, specify, and implement new process system solutions to support volume growth and new product introduction based on stakeholders' input and in collaboration with internal and external partners.
• Analyze, troubleshoot, and improve process systems, including manual and automated/semi-automated reagent formulation, dispense, labeling, and packaging in a cGMP environment, process utilities, and clinical lab processes.
• Develop and maintain documentation (standard operating procedures, engineering procedures, user requirements specification, commissioning, etc.) necessary to ensure consistent, high-quality results.
• Represent discipline on internal committees and technical conferences.
• Act as an SME in at least one technical discipline/system and mentor peers in this area.
• Provide technical support for engineering, manufacturing, and maintenance groups, ensuring appropriate change control and engineering best practices are followed.
• Lead or participate in investigations and troubleshooting of process systems associated with internal review, CAPA, audits or complaints.
• Lead initiatives to improve process, capability, reliability, and cost reduction activities.
• Lead or support equipment design, installation, and commissioning activities, support equipment qualification and validation.
• Perform engineering calculations to evaluate process capabilities and throughput of manufacturing components to achieve optimal cycle times.
• Review process system engineering specifications and drawings.
• Prioritize, plan and drive projects to completion through disciplined methodology and tools.
• Work cross-functionally to specify, define, and design process system requirements.
• Apply technical proficiency, creativity, collaboration with others, and independent thought.
• Ability to lead effectively in team situations as well as work independently.
• Excellent oral and written communication and interpersonal skills.
• Apply engineering practices and skills to perform a wide variety of standard and non-standard activities.
• 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 designated schedule.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work seated for approximately 70% of a typical working day. Ability to work standing for approximately 30% of a typical working day.
• Ability to lift up to 50 pounds for approximately 5% of a typical working day.
• Ability and means to travel 20% between local Madison locations.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor's Degree in Engineering or field as outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience as outlined in the essential duties.
• 8+ years of experience in process, production and/or manufacturing engineering.
• 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

• Specific engineering expertise in process engineering with the ability to apply knowledge in a hands-on environment.
• Experience with reagent formulation and supporting process utilities.
• Experience in an FDA-regulated industry.
• Experience performing root cause analysis.

Salary Range:

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.

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