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Global Computer Validation Specialist
Ref No.: 17-15890
Location: Marlborough, Massachusetts
 Job Title: Computer Validation Specialist  (IT)
Hands on position responsible for authoring test scripts and other CSV documents required for the validation of GAMP 5 Category 4 (configurable off the shelf) computer systems.  Candidates should be familiar with COTS systems used for clinical development and quality activities in a pharmaceutical environment.  Work with business users and Information Technology to ensure the systems remain in a validated state through appropriate change control procedures.
Create and/or review computer system validation test scripts, validation schedules, risk assessments, requirement specifications, protocols and reports, traceability matrices, and validation summary reports according to the timelines in the project plan.  Review applicable procedures and system training manuals as applicable. Participate in project team meeting. (85%)
Document requirements for business requirements, system security, user roles, workflows, data flows, GxP requirements and how these systems fit into the larger IT infrastructure. (10%)
Work with IT and User Groups to: (a) evaluate change control requests, (b) assess regulatory risk associated with such requests and (c) determine the corresponding validation requirements for such changes. (5%)
Skills
2 – 3 years' experience writing CSV test scripts, protocols and summary reports
Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline. 
Knowledge and skills (general and technical):
Sufficiently knowledgeable of FDA/EU Regulatory Requirements and industry best practices for computerized system validation to complete tasks
Understands lifecycle approach as well as risk based approach to validation
Generally familiar with GXP regulations particularly in the GCP and Quality areas
Able to work both independently and as a member of a cross-functional project team
Good written and oral communication skills
Good problem solving skills
Microsoft products such as Word, Excel, Project, and Visio.
Familiar with Information Technology principles, functionalities and capabilities of computer systems; and how computer systems relate to and integrate with larger corporate IT infrastructures