• Operations Support Engineer

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

    The Process Support Engineer will provide front line operational support to production and will be the primary liaison between project engineering resources and production. The Process Support Engineer will also provide significant support to internal and external partners to install, commission, and qualify equipment. This role is accountable for triaging equipment failures, identifying root causes, resolving performance issues, and implementing corrective / preventative actions using all resources available. The Process Support Engineer will be responsible for monitoring key performance indicators and working with other engineering resources to identify and implement process improvement and cost saving opportunities. This role requires broad perspective, sound engineering problem solving, and superior collaboration skills.

    Essential Duties and Responsibilities

    • Troubleshoot and improve automated/semi-automated reagent dispensing, labeling and packaging production processes, in a cGMP environment.    
    • Develop and maintain production documentation (standard operating procedures, user requirements specification, system specifications, etc.) necessary to ensure consistent, high-quality products.
    • Provide technical support for production, ensuring appropriate change control and validation practices are followed for manufacturing, product finishing processes.
    • Develop and execute commissioning protocols to demonstrate effectiveness and impact of changes to automated / semi-automated systems.  Support qualification protocol development and assist as needed that validation team during execution.
    • Monitor metrics for automated filling and packaging equipment efficiency.  Communicate performance metrics and recommendations for improvement to Operators, Quality, and Management.  Develop and implement actions for process improvements based on findings. 
    • Provide engineering support for internal and external preventative maintenance activities on major equipment.  Communicate findings and follow up actions to system owners.  Lead execution of non-routine maintenance activities with internal and external resources.
    • Participate in investigations and troubleshooting of manufacturing processes associated with internal review, CAPA, audits, or complaints.
    • Lead projects to improve production quality, capability, reliability, or reduce costs. 
    • Develop and maintain robust, easy to follow production and maintenance instructions.  Train operators and maintenance staff on operating procedures. 
    • Support equipment installation, commissioning, and qualification activities.


    Occasional Duties and Responsibilities

    • Up to 10% travel may be required


    Mandatory Skills

    • Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to problem solving, troubleshooting, and process improvements.
    • Experience in operation and troubleshooting automated production systems, with the ability to apply knowledge in a hands-on environment.
    • Experience with Allen Bradley software including one or more of the following RSLogix, RSLinx, or Factorytalk.
    • Hands-on experience troubleshooting Allen Bradley CompactLogix controllers.
    • Demonstrated ability to prioritize, plan, and drive projects to completion through disciplined project management methodology and tools.
    • Proven ability to lead effectively in team situations as well as work independently.
    • Excellent oral and written communication and interpersonal skills.
    • Experience with statistical process controls, DOE, FMEA, analysis of variance, and other quality tools.
    • Experience in commissioning, process validation, qualification and verification activities.
    • Experience with hands-on equipment maintenance, adjustment, or repair preferred.


    Education and Experience

    • Bachelors degree in engineering or related field, or relevant on-the-job experience.
    • Minimum of two years of experience in functions such as manufacturing, process engineering.
    • Experience in a reagent formulation, dispense and fill operation is strongly preferred.
    • Experience creating and reviewing drawings in AutoCAD or SolidWorks.
    • Experience in an FDA-regulated industry preferred.
    • Demonstrated experience with equipment procurement, installation, qualification and validation.
    • Experience performing root cause analysis.


    Physical Requirements

    • Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
    • Ability to sit for an extended period of time.
    • Ability to stand for extended periods of time and up to 6 hours at a time.
    • Ability to travel (by land and air), both domestically and internationally, on occasion.
    • Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
    • Constant walking or motion to coordinate work and interact with co-workers.
    • Ability to lift and move up to 40 pounds on an occasional basis.
    • Assembly/disassembly of equipment with hand tools.
    • Ability to work in controlled environments and use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, beard nets, hair nets, booties, hearing protection, etc.) and follow safety guidelines while in the lab etc. for extended periods of time.


    Exact Sciences is 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 is available to any applicant or employee for inspection upon request. 


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