CSV Engineer

Arrowtek Technologies is looking for CSV Engineer for laboratory instruments qualification projects for our client in Vacaville, CA. This critical role leads to the Computer System Validation (CSV) lifecycle for Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and direct instrument integrations if required. The ideal candidate ensures data integrity and system compliance for novel therapeutic and product manufacturing., * Validation Lifecycle Management: Author, execute, and review validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), and Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols.

• Instrument Integration: Oversee the mapping and validation of standalone lab instruments (e.g., balances, HPLCs, pH meters) to the LIMS network, ensuring flawless, bi-directional data transfer.
• Regulatory Compliance: Enforce compliance with GMP/GxP standards, Data Integrity principles, and 21 CFR Part 11 requirements for electronic records and signatures.
• Risk Assessments & GAMP 5: Facilitate risk assessments to identify system impact and apply proportionate validation efforts aligned with GAMP5.
• Change & Incident Management: Oversee system upgrades, patches, and configurations, ensuring all changes are formally assessed and validated prior to production release.
• Cross-Functional Collaboration: Partner with Quality Assurance (QA), Information Technology (IT), and Lab Operations to translate business workflows into digital, validated processes.

Do you have experience in User training (technical support)?, Do you have a Bachelor's degree?, * Education: Bachelor's degree in Life Sciences (Chemistry, Biology, Microbiology) or Information Technology/Computer Science, Chemical Engineering .

• Experience: Minimum \ (3-5+) years of hands-on CSV experience in a pharmaceutical or highly regulated GxP laboratory environment.
• System Knowledge: Direct experience working with enterprise LIMS (e.g., Thermo Fisher Sample Manager, Labware) and instrument software (e.g., Empower, TOC, LabX).
• Compliance Expertise: In-depth understanding of FDA regulations, EU Annex 11, Data Integrity, and industry validation frameworks.
• Soft Skills: Exceptional technical writing capabilities, strong stakeholder management, and the ability to train lab personnel on validated software.