Validation Engineer

2 weeks ago


Waltham, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time
Job Summary

At Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Validation Engineer 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, 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 to determine GxP applicability of the system, associated risk, and resulting validation activities per risk.
    • Support the 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.
    • Provide validation support during the operational phase by performing change impact assessments, determining the required level of testing, authoring, and executing test scripts related to the change and change qualification report.
    • Support periodic review of computer systems and support periodic user access review of computer systems/computerised equipments.
    • Support business administration of the electronic system (ValGenesis) used for validation lifecycle management.
    • Support training of end users on the electronic system (ValGenesis) used for validation lifecycle management.
    • Support management of Validation Templates in ValGenesis in terms of authoring/updating templates.

Requirements

• Bachelor's degree in a Science or Engineering discipline with 5 years relevant experience in computer system validation.
    • Experience in computer systems supporting R&D functions.
    • Experience with ValGenesis is a plus. 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.

What We Offer

Katalyst Healthcares and Life Sciences offers a dynamic and challenging work environment with opportunities for professional growth and development. We are committed to providing our employees with the resources and support they need to succeed in their roles.
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