COMPUTER SYSTEM VALIDATION SPECIALIST BOTHELL, WA Hybrid Work Schedule: 2-3 Days Per Week.
Bachelor's degree in a life sciences or engineering discipline or equivalent industry experience.
2+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures.
Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records, and electronic signatures.
Familiar with development of CSV documentation (Validation Plans, Requirements / Specifications / Assessments, Test Scripts [IQ / OQ / PQ], Summary Reports, Trace Matrices, SOPs, etc.).
Familiar with diverse computerized systems, such as computer-controlled laboratory instruments (stand-alone), MES, ERP, LIMS, Validation Lifecycle Management Software, QMS.
Experience in following CSV methodology for system evaluations, changes and implementations.
Ability to work independently.
Experience implementing controls directly supporting Data Integrity efforts is a plus.
The Computer Systems Validation (CSV) Engineer works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
This role is an individual contributor.
The CSV Specialist will partner with Business Owners, Technical Owners and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.
The CSV Specialist will have primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant procedures and regulations.
This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.
Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.