Myriad Genetics, Inc.

Process Sustaining Engineer II

Location US-UT-Salt Lake City
Posted Date 1 week ago(2/12/2018 4:15 PM)
Job ID
2017-6683
Name
Myriad Genetics Laboratories

Overview

Position focusing on MGL product and process sustaining activities including Operations support, risk management, statistical analysis, and verification/validation/research study support. Process Sustaining Engineer applies a systematic, scientific, and analytical engineering approach to the laboratory processes to maintain high quality results and mitigate potential risk. This position applies scientific and engineering principles toward improvement of efficiency, quality, and cost of MGL laboratory processes. This position will collaborate cross-functionally with Quality Assurance, Technical Development, and other Operations teams to support high value product and process improvement activities and development

Responsibilities

Each employee’s specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows:

Operations Support/Sustaining Engineering

  1. Provide analytical and process engineering support to maintain and improve product and production processes in MGL.
  2. Interacts with product design and development teams personnel to support process and design compatibility.
  3. Provide technical support to Operations teams to help execute various Quality Management System policies including, but not limited to, risk management, quality metric analysis, control and reaction plans.
  4. Work with Quality Assurance and Operations teams to identify, correct, and prevent product quality issues.
  5. Support and collaborate in cost reduction, waste elimination, and productivity improvement projects.
  6. Support process and design improvements for future products based on key learnings from sustaining programs.

Risk Management

  1. Lead and support risk management of CAPAs to determine risk level for proper action.
  2. Works with development and quality to manage risk associated with new design.
  3. Lead, support, update, and maintain risk and hazard analysis documentation for design and process.

Statistical Analysis

  1. Ensure process control and capability through engineering controls and other effective process management methods.
  2. Develop skills to support and operationalize control and reaction plans, which include statistical process control (SPC) and process capability monitoring for early detection of possible epidemic problems and generate input for new design projects.
  3. Collaborate on complex design of experiments (DOE) that scientifically confirm performance and reliability.

Verification, Validation, and Research Activity Support

  1. Collaborate with Operations and other teams on protocols and reports for verification and validation studies.
  2. Analyze data against acceptance criteria.
  3. Design reports to track metrics during execution.
  4. Facilitate data retention activities in collaboration with project management in compliance with QMS.
  5. Design and collaborate on SQL queries to acquire data and identify samples.
  6. Select, procure, and de-identify samples.

Departmental Responsibilities

  1. Train and mentor entry level and new team members.
  2. Conduct work independently and maintain project schedules in agreement with supervisor.
  3. Carry out special projects and all other additional duties as assigned.
  4. Continuous professional development.

Qualifications

  1. Bachelors of Science degree in engineering, or related science with 5+ years of relevant experience or Master’s degree in engineering, or related science with 3+ years of relevant work experience
  2. CQE or CRE required
  3. Intermediate level of knowledge with SQL
  4. Intermediate level of knowledge of Excel
  5. Knowledge of Minitab, R, or similar
  6. Knowledge and experience working with quality management systems and FDA regulation
  7. Knowledge of CAP/CLIA as well as ISO 13485 and 14971 standards highly desired
  8. Experience with assessing quality and compliance impact on products for design and process changes
  9. Experience in design verification and validation activities
  10. Highly motivated individual that can work independently

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.

About Our Company

Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

 

Myriad is an equal opportunity employer and as such, affirms in policy and practice to recruit, hire, train and promote, in all job classifications without regard to race, color, religion, gender, age, sexual orientation, gender identity, national origin, disability status or status as a protected veteran.

 

Reasonable accommodation will be provided for qualified individuals with disabilities and disabled veterans in job application procedures. We believe that diversity lends a regional, national, and global advantage to the clients we serve. Our workforce consists of dynamic individuals, with a range of backgrounds, talents, and skills.

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