• Process Engineer

    Job Locations US-WI-Madison
    Req No.
    2019-3722
    Category
    Manufacturing Operations, Facilities & Security
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Process Engineer partners with internal and external stakeholders to complete field support, commissioning and start-up activities, as well as lead initiatives to further streamline manufacturing and equipment operations.  The manufacturing systems and equipment supported by this position includes, but is not limited to, automated and manual formulation, distribution, cleaning, and clean utilities equipment.  Additionally, this role will be responsible for system improvements and optimization of production processes to improve throughput and increase efficiency as well as support of maintenance, repair, service, and monitoring of production systems for Exact Sciences Corp. and Exact Sciences Laboratories. This role will provide project management for assigned cross functional initiatives with guidance from senior team members and leadership.

    Essential Duties and Responsibilities

    • Based on stakeholders’ input and in collaboration with internal and external partners conceive, develop, and implement process improvements to support automated and manual manufacturing processes. 
    • Communicate recommendations, action plans, and project status to peers and leadership in engineering, production, quality, and other departments.
    • Support existing manufacturing processes including hands-on troubleshooting, performance monitoring, equipment set up and adjustment, repair, planned maintenance, and implementation of new products.
    • Participate on engineering teams to support design, start-up, and commissioning of new systems.
    • Lead initiatives to analyze, troubleshoot and improve processes, including manual and automated batch formulation, clean-in-place, clean utility systems, and semi-automated reagent formulation, dispensing, labeling and packaging in a cGMP environment and/or clinical laboratory diagnostic sample testing automation in a CAP/CLIA environment. 
    • Provide support to production/operations, which includes, recommending and assisting with process changes to improve productivity as appropriate.
    • Ability to trouble-shoot automated systems, communicate findings to automation support engineers, and test implemented solutions.
    • Seek new and better technologies and methods to increase process and equipment performance.
    • Develop and maintain documentation (standard operating procedures, user requirements, design specifications, component specifications and selection, commissioning protocols, etc.) necessary to ensure consistent, high-quality projects.
    • Provide technical support, ensuring appropriate change control practices are followed for manufacturing processes.
    • Lead or participate in investigations and troubleshooting of manufacturing processes associated with internal review, CAPA, audits, or complaints.
    • Support new equipment specification, design, installation, commissioning, and qualification activities.
    • Carry out other duties, responsibilities, and projects as may be assigned, in an effective manner.
    • Support and comply with the company’s Quality Management System policies and procedures.
    • Regular and reliable attendance.
    • Ability to work normal schedule of Monday through Friday business hours.
    • Ability to lift up to 50 pounds for approximately 10% of a typical working day.
    • Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day.
    • Ability to work in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
    • Ability to comply with any applicable personal protective equipment requirements.
    • Ability to travel approximately 10% of working time.

    Qualifications

    Minimum Qualifications

    • Bachelor’s degree in Chemical, Mechanical, or Industrial Engineering or related technical field; or high school degree/GED and 4 years of relevant work experience in lieu of degree.
    • 1+ years working in support of automated and manual processes.
    • 1+ years of experience managing projects.
    • Excellent problem-solving skills.
    • Solid communication skills and ability to communicate effectively across all organizational levels.
    • Authorization to work in the United States without sponsorship.
    • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

    Preferred Qualifications

    • Working knowledge of statistical techniques, problem solving techniques, DMAIC methodology and quality management systems.
    • Knowledge of quality tools such FMEA, Root-Cause-Analysis, and Corrective Actions.
    • Knowledge of statistical methods (6 Sigma, SPC, DoE).
    • Experience working in a cGMP / ISO 13485 compliant manufacturing environment.
    • Experience with automated production equipment.

    #LI-MO1

    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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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