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:
• 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., DeltaV 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

Benefits:
• 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