Computer System Validation consultant
Job in
Seattle, King County, Washington, 98101, USA
Listed on 2026-07-01
Listing for:
Futran Tech Solutions Pvt. Ltd.
Full Time
position Listed on 2026-07-01
Job specializations:
-
IT/Tech
IT Consultant, Systems Analyst, Data Analyst, IT QA Tester / Automation
Job Description & How to Apply Below
CSV Consultant Opportunity
Assurea is looking for CSV consultants for our pharmaceutical/biotech client based in the greater Seattle area. Travel to site is required.
Job Description andQualification:
- 3 to 5+ years of computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is required
- Author, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTM
- Develop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systems
- Knowledge of regulatory requirements and standard best practices, (e.g. GLP/GMP, 21 CFR Part 11, Annex 11, GAMP5) with respect to computerized systems and data integrity
- Write and provide support for all CSV related deviations, discrepancies and change control documentation
- Work closely with project manager and CSV lead for validation activities and implementation timelines
- Efficient and skilled in writing documents / formatting / understanding Microsoft office and able to create templates etc.
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