Job Description
Roles & Responsibilities:
Lead and manage validation activities for LIMS and MES implementations, upgrades, and integrations.
Develop and review Validation Master Plans (VMPs), Validation Protocols (IQ, OQ, PQ), and Test Scripts in compliance with GAMP and company policies.
Oversee validation deliverables across the System Development Life Cycle (SDLC) including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Traceability Matrices.
Perform and document risk assessments, impact assessments, and change control validations for LIMS/MES systems.
Ensure compliance with CFR Part , EU Annex , GxP, and Data Integrity requirements.
Collaborate with business users and technical teams to validate system configurations, interfaces, and data migration activities.
Conduct periodic reviews, requalification, and system audit readiness for validated syst...
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Job Details
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Location
Hillsboro, Oregon
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Job Type
Full-time
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Category
Computer Occupations
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Posted Date
June 24, 2026
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Application Deadline
August 03, 2026