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Validation Engineer
Ref No.: 18-25916
Location: Durham, North Carolina
Start Date / End Date: 04/30/2018 to 12/31/2018
Artech is currently seeking to add to the below position
Posting Title:  Business Analyst/Validation Engineer
Job Id:              AZNJP00005703
Location:         Durham, NC
Duration:         8 months
  • Act as the cross site Lead for the creation of the User Requirement Specification (URS).
  • Arrange and lead workshops to accurately map, and where possible, simplify business workflows and translate them into unambiguous user requirements.
  • Organize requirements in an optimal way, aspiring to create a state of the art URS i.e. covers all aspects of the future robot in a human friendly way.
  • Liase with all supporting functions whose input is required for the creation of the URS e.g. Quality Assurance, IT and SHE.
  • Secure that all work is performed according to the Quality Management Framework and cGMP standards.
  • Liase with vendor to ensure design aligns with the URS.
  • Manage SAT, FAT, PQ and IQ/OQ activities and documentation.
  • Support the Business in reviewing URS responses from potential suppliers of the robot.
  • Support the Project Manager with updating schedules, costs, and risks as needed.
Minimum Requirements:
  • Degree in a relevant science or engineering discipline
  • Minimum 5 years’ experience of leading work around development of URS documents related to automation set within a GxP regulated environment.
  • Previous experience around automating analysis of inhalers is desirable.
  • Knowledge of GAMP5 Requirements is desirable.
Skills and Capabilities
  • Proven communication and organizational skills for global working
  • Able to travel up to 50% time. Candidate must be open to travel to Sweden and France. Travel is non-negotiable.
Please apply on our company website ( with reference to job ID, or contact me at / 973.967.3540
Nisha Samuel
Assistant Manager- Staffing

Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3540 | Fax: 973.998.2599
Email: | Website:

About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check:
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