Validation Specialist – CSV / CSA

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

We are seeking a Validation Specialist with 3–5 years of experience in Computer System Validation (CSV) and Computer Software Assurance (CSA) within the pharmaceutical, biotechnology, or medical device industry. The candidate will support the implementation, validation, and lifecycle management of GxP-regulated computerized systems, ensuring compliance with FDA and EU regulatory requirements.

Experience with SaaS platforms, AI/ML-enabled applications, and Regulatory Affairs systems is highly preferred.

Key Responsibilities:

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

Required Skills & Qualifications:

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related field.
• 3–5 years of CSV/CSA experience in pharmaceutical, biotechnology, or medical device environments.
• Hands-on experience implementing and validating GxP computerized systems.
• Strong knowledge of CSA, CSV, GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Experience with validation documentation, technical writing, risk assessments, UAT, and change control.
• Understanding of validation lifecycle management and risk-based validation approaches.
• Strong communication, documentation, and stakeholder management skills.