Validation Engineer - Katalyst CRO : Job Details

Validation Engineer

Katalyst CRO

Job Location : Framingham,MA, USA

Posted on : 2025-08-06T01:07:28Z

Job Description :

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Responsibilities
  • Execute validation activities in computerized systems and ensure 21 CFR Part 11 compliance. Knowledge of GAMP is required.
  • Prepare trace matrices to ensure requirements are tested to meet the software's intended use.
  • Conduct risk assessments for functional requirements and develop testing strategies, implementing technical and procedural controls as mitigation measures.
  • Prepare SOPs and work instructions for equipment and software-based systems.
Requirements
  • 6 to 8 years of experience as a Non-Product Software Validation Engineer within the manufacturing sector (Medical devices or Diagnostics).
  • Experience in validating non-product software for manufacturing equipment according to regulatory standards (FDA, ISO).
  • Ability to prepare and review functional requirements, design, and testing documents.
  • Experience reviewing SLC deliverables such as validation plans, change requests, user requirements, functional requirements, risk assessments, IQ/OQ/PQ, traceability matrices, release notes, and certification summaries.
Additional Details
  • Seniority level: Mid-Senior level
  • Employment type: Contract
  • Industry: Pharmaceutical Manufacturing
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