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Traveling Business Analyst / Validation Engineer

Location: Durham, NC, United States
Job # 10968943
Date Posted: 05-16-2018
Traveling Business Analyst / Validation Engineer
Durham, NC 27703

Pay Rate: $50-$55/hour (DOE)
Start: ASAP
Contract to Hire

 
Our client is a growing, dynamic Fortune 100 company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma.  We are seeking to hire individuals that bring energy and passion to deliver the medicines that provide patients and healthcare provider’s therapies to achieve better clinical outcomes. The principal objective of this position is to be responsible for overseeing the development of a new analytical robot for inhaler testing. This position will require frequent travel to Sweden and France as well so be comfortable with travel.

Duties and 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. 
Qualifications:
  • 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. 
  • Must be comfortable with traveling up to 50% of the time.
If qualified, please respond back with a resume saved as word document to be considered. #DI
 
 
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