Process Development & Automation Scientist I

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Position Overview

The Process Development & Automation Scientist I provides services of a technical nature to support the development, implementation, and maintenance of automation, IT, and software systems used in the clinical laboratory. The Scientist I, Process Development and Automation will perform moderate and highly complex analytical processes to support feasibility and validation studies. This includes wet lab testing for feasibility, verification and validation of lab automation, workflows and software. This role will also be responsible for performing user acceptance testing (UAT), and validation of Laboratory information system (LIS) system changes and upgrades. This role will collaborate with end users and LIS developers to address needed improvements to current modules, design requirements for new test systems, validation, and implementation of the changes. Role is beginning to make significant contributions in the requirements gathering, development, testing and implementation of new technologies and/or automated platforms.

Essential Duties

Include, but are not limited to, the following:

• Assist in UAT testing.
• Applies defined protocols and procedures; conducts moderate level testing activities and data analysis. Applies technical knowledge to develop company products and to recommend product enhancements.
• Able to troubleshoot anomalies.
• Conducts moderately complex scientific design, platform eligibility testing, systems integration, or performance testing.
• Able to train others on the proper use of Exact Sciences equipment.
• Exercises independent judgment within generally defined practices and procedures in selecting methods and techniques of obtaining solutions.
• Able to recognize need for deviation.
• Scenario based decision making.
• Able to present, organize and convey problems or issues across functional areas within the same product line/platform/business organization.
• Assists in preparing information for design documentation and design reviews.
• Contributes as team member to meet pre-defined goals.
• Encourages team participation.
• Learning and building knowledge of products, company, business, and industry.
• Understands individual impact to company work processes and deliverables.
• Collaborate with different laboratory and support groups to shape design of lab improvements that meets user needs while efficiency, process robustness, and scalability are improved upon.
• Edit and review controlled documents within the laboratory document control system to support changes or implementation of software and process changes.
• Work with training teams to ensure timely and effective process change implementation in the laboratories.
• Perform moderate and/or highly complex analytic processes, without direct supervision.
• Evaluate data to calculate statistics for assessment of current and new processes.
• Work with all the laboratory management teams as a mentor throughout all the implementation stages, such as scoping, planning, implementing, and maintaining.
• Suggest cost-effective laboratory procedures or protocol changes.
• Implement changes in response to new technology and laboratory procedures; recommend and implement changes to ensure ongoing high-quality performance of laboratory processes, as assigned.
• Maintain all records and follow procedures to meet regulatory requirements such as FDA, CLIA, and/or CAP.
• Ability to work cross-functionally across different operations within the organization.
• Make decisions analytically, without direct supervision.
• Ability to think strategically, especially in relation to long term impacts of systems and processes.
• Excellent verbal and written English communication skills.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Must be highly motivated and able to work both independently and as a member of a team.
• Adaptable, open to change and able to work in ambiguous situations and respond to new information and unexpected circumstances.
• Effectively communicate issues/problems and results that impact timelines, accuracy, and reliability of data.
• Ability to make recommendations from data analysis.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the companys Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work designated schedule.
• 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 on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelors Degree in Clinical Laboratory Science, Medical Technology, or a relevant Chemical or Biological Science field.
• 3+ years of experience working in a clinical laboratory.
• Strong working knowledge of clinical laboratory operations and activities.
• Demonstrated ability to lead project work effectively in team situations as well as work independently.
• Demonstrated ability to follow procedures and maintain detailed records.
• Demonstrated ability to manage time and competing priorities.
• Demonstrated ability to take scientific bench protocols from the bench to automation system.
• Demonstrated ability to multi-task and work productively in a demanding environment with changing priorities while displaying a wide degree of creativity and latitude.
• 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

• American Society for Clinical Pathology (ASCP) or equivalent certification.
• 1+ years of experience integrating laboratory information management systems (LIMS) with automated systems.

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 disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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