JVT Advisors

Validation Engineer

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Location: Waltham, Massachusetts 02451
Employment Type: Contract

Job Description

Contract Length: 6 months

 

Job Summary: This individual will be responsible for promoting current computerized system validation practices with particular focus on impact to patient safety, product quality and data integrity.

 

Responsibilities:

  • Subject matter expert of validation of Computerized Systems and associated business system interfaces.
  • Work within cross-functional project teams representing Validation to ensure projects are completed in line with procedures, regulations, and business needs. Measure and report project execution progress.
  • Responsible for decisions that impacts the project implementation, solving complex technical problems without compromising compliance/ Regulatory requirements
  • Performing System based Risk Assessments to ensure validation efforts are directed at the systems that have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management.

 

Requirements:

  • Bachelor’s degree or higher in relevant computer/regulatory/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality orientation.
  • 5 years of relevant experience in a high volume commercial / clinical pharma / healthcare facility, supporting computer applications.
  • Experience with Enterprise and Global Quality Systems, Data Visualization tools, Medical Inquiry (Medical Affairs), Manufacturing System is a plus.
  • Knowledge of GxP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, EudraLex Volume 4 and Annex 11.

 

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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