Lead Validation Engineer role at Dotmatics overseeing computer system validation for the Luma platform under GxP requirements. Responsible for validation lifecycle documentation, regulatory compliance (21 CFR Part 11, EU Annex 11, GAMP 5), and mentoring validation teams across the software development lifecycle.
Responsibilities
Author, review, and approve validation master plans and lifecycle documentation following GAMP 5 principles
Collaborate with software quality and DevOps teams to develop and execute automated IQ, OQ, and PQ protocols
Serve as subject matter expert on regulatory standards and validation methodologies for stakeholders
Mentor junior validation team members and provide training on CSV principles and compliance expectations
Guide product, engineering, and quality teams on validation strategy and best practices throughout SDLC
Requirements
Expert knowledge of GAMP 5 framework and risk-based validation approaches
Deep understanding of 21 CFR Part 11, EU Annex 11, ICH Q10, and ISO 9001 standards
... documentation requirements. - Mentor/lead junior validation team members and QA staff on validation methodologies and documentation best practices. - Serve as Luma subject matter expert for GAMP5, 21 CFR Part, EU Annex 11, and applicable ISO standards. - Provide validation guidance and training to engineers, QA analysts, ...
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