CSV Engineer

SOKOL GxP Services is seeking an experienced  Computerized Systems Validation (CSV / CSA) Engineer  to support validation of computerized systems used in  pharmaceutical manufacturing, laboratory, and quality operations . This role is responsible for ensuring systems are validated, maintained, and compliant with  cGMP, FDA, and global regulatory requirements , using a  risk-based approach aligned with GAMP 5 and Computer Software Assurance (CSA)  principles.

We are seeking positions for both QC related equipment and Manufacturing related equipment.

Key Responsibilities :

• Lead and execute  CSV / CSA activities across the full system lifecycle , from concept and implementation through operation and retirement
• Develop, review, and maintain validation deliverables, including  Validation Plans, URS, Risk Assessments, Test Scripts, and Summary Reports
• Apply  risk-based CSA methodologies  to define appropriate validation strategies and testing rigor
• Support validation of  GxP computerized systems , including MES, LIMS, QMS, ERP, SCADA, DCS, PLCs, and standalone instruments
• Ensure compliance with  21 CFR Part 11, Annex 11, and data integrity (ALCOA+)  requirements
• Perform and document  system risk assessments , including GAMP 5 categorization and impact assessments
• Execute and / or review  functional, integration, and user acceptance testing (UAT)
• Support system  configurations, upgrades, patches, and periodic reviews
• Manage and support  validation deviations, change controls, and CAPAs
• Collaborate with  IT, Automation, Quality, Engineering, and business stakeholders
• Support  internal audits, regulatory inspections, and vendor assessments
• Maintain validation documentation in accordance with  document control and QMS requirements

Requirements

Benefits