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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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