CSV Engineer

Overview

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.

• 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

• Bachelor’s degree in Engineering, Chemistry, Biology, or a related scientific discipline
• 4+ years of CSV/CSA experience in a regulated pharmaceutical or biotechnology environment
• Strong understanding of GMP regulations and validation lifecycle requirements
• Hands-on experience validating GxP computerized systems
• Knowledge of FDA regulations, 21 CFR Part 11, Annex 11, and data integrity principles
• Familiarity with automation platforms (e.g., Delta
  
  V or similar)
• Strong technical writing, documentation, and organizational skills
• Experience supporting aseptic manufacturing, sterile fill-finish, or cleanroom environments preferred
• Ability to manage multiple validation efforts in a fast-paced consulting environment

• Competitive salary
• Health, dental, and vision insurance (for eligible full-time employees)
• 401(k) plan with company match (for eligible full-time employees)
• Paid time off and company holidays
• Interest free relocation assistance loan
• Continuous professional development and training opportunities through SOKOL GxP Academy