Global Computer Validation Specialist

Education level and/or relevant experience(s):

• 2 – 3 years experience writing CSV test scripts, protocols and summary reports in global environments
• 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/MHLW Regulatory Requirements and industry best practices for computerized system validation to complete tasks
• Experience working with global teams particularly with team members from Japan
• 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

$45/hr

6+ months