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Validation Engineer

Company:
Artech Information Systems
Location:
Durham, North Carolina, United States
Posted:
July 17, 2018
Description:

Job Description:

Posting Title: Business Analyst / Validation Engineer

Job Id: AZNJP00005703

Location: Durham, NC

Duration: 8 months (Contract to Hire)

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.