Validation Specialist

8 hours ago


Waltham, Massachusetts, United States GForce Life Sciences Full time
Job Title: Validation Specialist

At GForce Life Sciences, we are seeking a highly skilled Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our computer systems and equipment.

Responsibilities:
  • Perform validation activities to support requirements gathering, validation planning, design qualification, and test execution.
  • Conduct system-based risk assessments to determine GxP applicability and resulting validation activities.
  • Support the validation team on all aspects of the computer system lifecycle, including development, review, and execution of validation documentation.
  • Provide validation support during the operational phase by performing change impact assessments and determining the required level of testing.
  • Support periodic review of computer systems and user access reviews.
Requirements:
  • Bachelor's degree in a Science or Engineering discipline.
  • 5 years of relevant experience in computer system validation.
  • Knowledge of cGMP regulations and guidelines, including U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4, and Annex 11.
  • Understanding of industry standards and best practices for computer system validation, such as GAMP 5 and ASTM E2500.
Preferred Qualifications:
  • Experience with ValGenesis.
  • Practical experience with quality risk management and risk-based validation approaches.

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