Validation Engineer

2 weeks ago


Waltham, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Conduct validation tasks that facilitate requirements gathering, validation strategy formulation, design qualification, development of test plans and scripts, execution of test procedures, discrepancy resolution, and creation of system description and validation summary documents.
  • Execute system-based risk evaluations to ascertain GxP relevance of the system, associated risks, and the subsequent validation actions dictated by the risk assessment.
  • Collaborate with the Validation Team throughout the entire lifecycle of computer systems and computerized equipment during both project phases and operational stages, which includes but is not limited to the development, review, and execution of validation documentation.
  • Provide validation assistance during the operational phase by performing change impact evaluations, determining necessary testing levels, and authoring and executing test scripts related to changes along with the change qualification report.
  • Aid in the periodic review of computer systems and facilitate periodic user access assessments of computer systems/computerized equipment.
  • Assist in the business administration of the electronic system (ValGenesis) utilized for managing the validation lifecycle.
  • Facilitate training sessions for end users on the electronic system (ValGenesis) employed for validation lifecycle management.
  • Support the management of Validation Templates within ValGenesis, including authoring and updating templates as necessary.
Required Qualifications:
  • A Bachelor's degree in a Science or Engineering field with a minimum of 5 years of relevant experience in computer system validation.
  • Proven experience with computer systems that support R&D functions.
  • Familiarity with ValGenesis is advantageous. Practical experience with quality risk management and risk-based validation methodologies is preferred.
  • Comprehensive 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.

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