GxP Validation Engineer – Systems & Compliance

Norgine B.V.; Cefn Hengoed; On-site; GBP 45,000 - 65,000; Full time

Job summary

Norgine is seeking a Validation Specialist to ensure that GxP-regulated computerised systems and related processes meet quality and regulatory requirements. The role involves providing practical validation expertise across the system lifecycle and applying risk-based principles to support compliance and data integrity.

You will plan, coordinate and carry out validation activities, develop and maintain validation documentation, perform testing, and support audits and regulatory enquiries by

Qualifications

• Bachelor's degree or equivalent in computer systems or related discipline.
• Experience with QA methodologies, review and reporting.
• Ability to interpret complex information and make sound decisions.

Responsibilities

• Plan, coordinate and carry out validation activities for GxP-regulated computerised systems.
• Develop, review and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
• Perform system testing and verification to confirm systems meet requirements.
• Support audits, inspections and regulatory enquiries with validation evidence.
• Collaborate with Quality, Manufacturing, Engineering, IT and external vendors to embed validation throughout the lifecycle.
• Contribute to validation standards, processes and continuous improvement.

Skills

GxP validation

Risk-based approach

Quality assurance

Documentation

Communication

Education

Bachelor's in computer systems

Job description

Norgine is seeking a Validation Specialist to ensure that GxP-regulated computerised systems and related processes meet quality and regulatory requirements. The role involves providing practical validation expertise across the system lifecycle and applying risk-based principles to support compliance and data integrity.

You will plan, coordinate and carry out validation activities, develop and maintain validation documentation, perform testing, and support audits and regulatory enquiries by