Manufacturing Engineer

Job Locations US-WI-Madison
Req No.
Manufacturing Operations
Regular Full-Time

Summary of Major Responsibilities

The Manufacturing Engineer leads collaboration efforts with internal experts and external partners to procure, install, commission, and maintain equipment, as well as implement processes to further automate reagent manufacturing, material handling, and molecular diagnostic testing. The Manufacturing Engineer will develop equipment/instrumentation requirements in support of manufacturing, monitor performance of the automated systems, and may serve as a technical expert to support supply chain relationships with contract manufacturing partners and vendors. Additionally, the Manufacturing Engineer is responsible for the supervision of maintenance, repair, service, monitoring and programming of automated production components and systems for Exact Sciences Corp. and Exact Sciences Laboratories. This role will provide superior project management services for assigned projects.

Essential Duties and Responsibilities

  • Based on stakeholders’ input and in collaboration with internal and external partners will conceive, specify, procure, and implement engineering controls installation and modifications to support new manufacturing solutions, process automation/improvement, clinical laboratory test procedure automation, volume growth, and new product introduction.
  • Support existing automation installations including implementation of new products, hands-on troubleshooting, equipment set up and adjustment, repair, planned maintenance, and performance monitoring.
  • Lead projects to analyze, troubleshoot and improve processes, including manual and automated/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. 
  • Develop and maintain documentation (standard operating procedures, user requirements, design specifications, component specification 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.
  • Collaborate with R&D and Operations/Lab Operations to ensure design for manufacturability elements are incorporated into product requirements and development activities to facilitate smooth transfer of products and processes into new or existing automation systems.
  • Lead or support new equipment specification, design, installation, commissioning, and qualification activities. 

Occasional Duties and Responsibilities

  • Up to 10% travel may be required


Mandatory Skills

  • Prior experience in specifying, selecting and integrating manufacturing systems and components including, but not limited to robots, material handling, programmable logic controllers(PLCs), machine vision and image processing, and digital and analog sensors is required.
  • Two or more years experience developing and commissioning automated systems in a cGMP, ISO or other regulated production environment
  • Demonstrated Allen Bradley PLC expertise.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Demonstrated ability to prioritize, plan, and drive projects to completion through disciplined project management methodology and tools.
  • Proven ability to lead project work effectively in team situations as well as work independently.
  • Excellent oral and written communication and interpersonal skills.
  • A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding environment with changing priorities.
  • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of data.
  • Proficient in MS Office Suite, Outlook, and Internet Explorer.
  • Experience with Microsoft Project or equivalent project management software.

Preferred Qualifications

  • Hands-on troubleshooting, equipment set-up, repair, and maintenance in a highly regulated environment.
  • Experience with DOE, FMEA, analysis of variance, and other quality tools.
  • Experience implementing and/or operating a data historian to maintain production records, optimize process performance and collect key performance indicators.
  • Familiarity with the application of GAMP (Good Automation Manufacturing Practices)
  • Experience with validation of computerized systems.

Education and Experience

  • Bachelors or Master’s degree in engineering or related field, or relevant on-the-job experience.
  • Minimum of five years of  experience in functions such as manufacturing, process engineering, or process development. 
  • Experience creating and reviewing drawings in AutoCAD and/or SolidWorks.
  • Experience in an FDA-regulated industry or similar regulated or ISO compliant experience
  • Demonstrated experience with equipment procurement, installation, commissioning, and qualification.   
  • Experience performing root cause analysis.
  • Experience specifying facility utility requirements for new manufacturing systems.

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 75 pounds on an occasional basis.
  • Assembly/disassembly of equipment with hand tools.
  • Ability to work in controlled environments requiring protective clothing over the head, face, hands, feet, and body, including in-ear or over-the-ear hearing protection.
  • Ability to work safely with hazardous substances.

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. The Company’s affirmative action program is available to any applicant or employee for inspection upon request. 


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