Metaminds · 1 day ago
Validation Engineer
Hillsboro, OR
Contract
Hybrid
Mid, Senior Level
3+ years expMetaminds is seeking a Validation Engineer II – CSV & Compliance to support IT/OT system owners with computer system validation and compliance for GMP-regulated manufacturing systems. The role involves executing validation lifecycle deliverables, maintaining documentation, and ensuring compliance with regulatory requirements.
Management Consulting
Hiring Manager
Sanjay San J
Responsibilities
Support validation and compliance activities for GMP-regulated IT/OT manufacturing systems (ISA-95 Level 2 & Level 3)
Execute Computer System Validation (CSV) lifecycle deliverables including plans, protocols, scripts, traceability matrices, and reports
Develop and maintain validation documentation such as URS, FS/DS, risk assessments, IQ/OQ/PQ protocols, and summary reports
Partner with system owners, QA, and engineering teams to ensure validated state is maintained across systems
Support change control, deviation management, CAPA, and periodic review activities
Ensure validation packages meet internal SOPs and regulatory requirements (FDA, GAMP5, GxP)
Assist with compliance reporting and audit readiness activities
Participate in system upgrades, patches, and new implementations from a validation perspective
Review vendor documentation and validation deliverables for compliance and completeness
Track validation tasks and provide status updates to stakeholders
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
3–6+ years of experience in Computer System Validation (CSV) in GMP-regulated environments
Strong understanding of GxP, GAMP5, 21 CFR Part 11, and data integrity requirements
Experience validating manufacturing, laboratory, or OT systems
Hands-on experience with validation lifecycle documentation and execution
Familiarity with change control and deviation processes
Experience working with cross-functional teams including QA, IT, and manufacturing
Strong documentation and technical writing skills
Company
Metaminds
MetaMinds is a global Business Consulting and Services firm, founded in 2024, delivering innovative technology and workforce solutions across the U.K., Europe, Canada, the USA, LATAM, Mexico, and India.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase