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Validation EngineerApply Now

Location: Waltham, Massachusetts 02451
Employment Type: Contract

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Job Description

Contract Length:  6+ months; hybrid position

Job Summary:   This person will support computer system/computerised equipment validation activities and ensure compliance.

Responsibilities:
 
  • Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.
  • Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.
  • Support Validation Team on all aspects of the computer system/computerised equipment lifecycle during projects and operational phase, including but not limited to development, review and execution of validation documentation.
  • Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.
  • • Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.
  • • Support Validation Team on all aspects of the computer system/computerised equipment lifecycle during projects and operational phase, including but not limited to development, review and execution of validation documentation.
Requirements:
 
  • Bachelor’s degree in a Science or Engineering discipline
  • 5 years relevant experience in computer system validation
  • Experience with computer systems supporting R&D functions
  • Practical experience with quality risk management and risk-based validation approaches.
  • Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
  • Understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500

Contact

Jared Potter
Principal Recruiter

He's a natural people person.


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