Job description
Position Overview
The Process Development Engineer II participates in many aspects of the design, development, automation, implementation, and support of instrumentation and process in laboratory operations. The Process Development Engineer II works on cross-functional teams that work to ensure instruments and processes meet stringent performance, regulatory, and operational requirements and are robust, efficient, and scalable. This role will lead aspects of the creation, monitoring, and improvement of standardized processes for engineering activities; including, but not limited to, software and instrument change or configuration management. Projects may be in support of research and development, manufacturing, and/or clinical laboratories. To support the development and implementation activities, the Process Development Engineer II will act as the subject matter expert on laboratory procedures used to process samples in next-generation sequencing (NGS) laboratory workflows.
Essential Duties
Include, but are not limited to, the following:
- Lead the design, development, optimization, testing, implementation, and maintenance of NGS automated processes, systems, and streamlined workflows for Exact Sciences Laboratories.
- Lead the design, development, testing, and qualification methods for equipment and processes; track and document results.
- Troubleshoot and resolve anomalies in laboratory processing, independently or as part of a cross-functional team.
- Operate and troubleshoot NGS instruments.
- Program robotic liquid handling workstations.
- Establish and collect requirements from end-users and stakeholders.
- Lead the design and implementation of custom mechanical parts for automated systems.
- Partner with laboratories and service and support to set standards and procedures for processes that ensure sustainability of standards.
- Perform data analysis and accurately interpret results.
- Train others on the proper use of equipment and processes.
- Lead the evaluation of laboratory instrumentation, robotics, and software.
- Represent engineering on cross-functional teams.
- Suggest and implement process improvements and enhancements.
- Participate in implementation of best practices in design control, change control, and configuration management.
- Work as an individual contributor and within teams.
- Apply excellent organizational and planning skills.
- Ability to learn and apply new methods and technologies quickly.
- Ability to communicate clearly and effectively in writing and verbally.
- Ability to integrate and apply feedback in a professional manner.
- Ability to follow standardized procedures, where required.
- Ability to prioritize and drive to results with a strong commitment to quality.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- 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 work designated schedule.
- Ability to work nights and/or weekends, as needed.
- 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 grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to comply with any applicable personal protective equipment requirements.
- May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
- Ability and means to travel between local Exact Sciences locations.
- Ability to travel 15% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s Degree in Engineering or related field as outlined in the essential duties; or Associates Degree in Engineering and 2 years of relevant experience as outlined in the essential duties in lieu of Bachelor’s Degree.
- 4+ years of experience in process engineering and/or laboratory automation.
- 2+ years of experience with the operation, maintenance, and troubleshooting of NGS instruments and laboratory equipment.
- Demonstrated ability to troubleshoot technical problems; especially those related to automated instruments.
- Demonstrated understanding with the design, development, testing, implementation, and/or support of automated sample-processing workflows as part of a cross-functional team, in a clinical or other regulated laboratory setting.
- Strong familiarity standard molecular biology techniques to include nucleic acid isolation, purification, and quantitation, DNA/RNA quantitation, qPCR, or NGS.
- Strong working knowledge of NGS instruments and laboratory equipment.
- Proficiency in using basic word processing and spreadsheet applications.
- 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
- Bachelor’s degree in Molecular Biology, Genetics, Biochemistry, Bioengineering, Mechanical Engineering, Chemical Engineering, or a closely related discipline.
- 4+ years of experience operating, programming, and testing instruments, such as liquid handling robotics and NGS instruments.
- General understanding of molecular biology, biochemistry, and physical chemistry to troubleshoot processes.
- Demonstrated mechanical aptitude.
If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email
jobs@exactsciences.com
.
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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