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Job Position: Computer Systems Validation (CSV) Specialist/ Engineer
Location: Bothell, WA 98021 (Hybrid)

Job Summary:

Hybrid on-site 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 the primary responsibility to ensure that routine tasks supporting the validation of electronic systems and applications are documented in accordance with the relevant Client procedures and regulations.
This includes coordination of system validation periodic reviews and audit activities as well as the support of computer system validation efforts for new system implementations and changes to existing systems.

The position has the following requirements:

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.

Primary Duties and Responsibilities:

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.
Author, review and/or approve applicable CSV documentation.
Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.
Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required).
Other related duties as assigned.

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