JVT Advisors

Validation and Compliance Engineer

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Location: Waltham
Employment Type: Contract

Job Description

Contract Length: 6 months

Job Summary: Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials, and product testing. Assists in equipment selection, specification, and negotiation of competitive pricing. Maintains all documentation pertaining to qualification and validation.

Responsibilities:

  • Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information Systems
  • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
  • Translate technical information and requirements into qualification/validation test design

Requirements:

  • Bachelor’s Degree: scientific background preferred
  • 5-7 years of pharmaceutical of FDA related validation experience
  • knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance
  • Strong interpersonal skills and demonstrated ability work independently
  • Organized and task oriented
  • Excellent written and oral communication skills – especially on technical topics
  • Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project

 

 

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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