Previous Job
Previous
Validation Engineer
Ref No.: 18-25916
Location: Durham, North Carolina
Start Date / End Date: 04/30/2018 to 12/31/2018
DESCRIPTION:
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
Responsibilities:
  • 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 (www.artechinfo.com) with reference to job ID, or contact me at nisha.samuel@artechinfo.com / 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: Nisha.Samuel@artechinfo.com | Website: www.artechinfo.com

 
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: www.artechinfo.com
Connect with Artech through Social Media
Learn more about our company including the latest events at Artech, new job opportunities, jobseeker tips, and more. Follow us on Facebook, Twitter, LinkedIn, Google+, and YouTube