GxP CSV/CSA Validation Lead for Regulated Systems

United Pharma; North Carolina; On-site; USD 85,000 - 105,000; Full time

Job summary

United Pharma seeks a Validation Specialist with 3–5 years of CSV/CSA experience to support the validation and lifecycle management of GxP-regulated computerized systems in the pharmaceutical environment.

You will ensure compliance with FDA and EU requirements, develop validation documentation, and collaborate with IT, Quality, and Regulatory Affairs to maintain validated states and drive continuous improvement.

Qualifications

• 3–5 years of CSV/CSA experience in pharma/biotech/medical devices.
• Hands-on experience validating GxP computerized systems.
• Knowledge of CSA, CSV, GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Experience with validation documentation and risk assessments.
• Strong communication and stakeholder management skills.

Responsibilities

• Lead and execute validation activities for GxP-regulated computerized systems across the lifecycle.
• Develop and maintain validation documentation (Validation Plans, URS, Risk Assessments, Test Scripts, UAT, Traceability Matrices, Validation Summary Reports).
• Apply CSA, GAMP 5, and risk-based validation methodologies to ensure regulatory compliance.
• Support system configuration, implementation, testing, upgrades, and post-implementation activities.
• Prepare and maintain SOPs, work instructions, and change control documentation.
• Ensure compliance with FDA 21 CFR Part 11 and EU Annex 11 and Data Integrity principles.
• Collaborate with IT, Quality, Regulatory Affairs, and business teams.
• Support user training, change management, and ongoing system maintenance.

Skills

CSV/CSA experience

Communication

Documentation

Stakeholder management

Risk assessments

Education

Bachelor's degree

Job description

United Pharma seeks a Validation Specialist with 3–5 years of CSV/CSA experience to support the validation and lifecycle management of GxP-regulated computerized systems in the pharmaceutical environment.

You will ensure compliance with FDA and EU requirements, develop validation documentation, and collaborate with IT, Quality, and Regulatory Affairs to maintain validated states and drive continuous improvement.