CSV Engineer

Duration: 6- 12 months (extendable)

Location: Seattle, WA (Onsite)

Job Description:

• 3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is required.
• Preferred MES/ DeltaV experience.
• 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.
• Have the ability to work with multiple clients and projects.

Best Regards,

Chetna

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