GxP Validation Engineer - 12-Month FTC

Norgine; Hengoed; Presencial; GBP 42 000 - 64 000; Tempo integral

Resumo da oferta

Norgine is seeking a Computer Systems Validation Engineer in Hengoed for a 12-month fixed-term contract. You will guide validation of GxP-regulated computerised systems, ensuring data integrity and regulatory compliance across the system lifecycle.

You will develop validation plans, perform testing, support audits and collaborate with Quality, Manufacturing, Engineering and IT teams to embed validation requirements with a risk-based mindset.

Qualificações

• Bachelor's degree in computer systems, engineering or related discipline.
• Experience with QA methodologies, data collection and analysis.
• Experience in planning, organisation and project quality management.
• Strong communication and collaboration skills.

Responsabilidades

• Plan, coordinate and carry out validation activities for new and existing 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 that systems meet defined business, quality and regulatory requirements.
• Support audits, inspections and regulatory enquiries by providing validation evidence.
• Work with Quality, Manufacturing, Engineering, IT and external vendors to assess changes and embed validation requirements throughout the system lifecycle.
• Contribute to validation standards, processes, best practice and continuous improvement.

Conhecimentos

Quality assurance

Data analysis

Planning & organisation

Requirements verification

Communication

Collaboration

Formação académica

Bachelor's degree in computer systems/engineering or related

Descrição da oferta de emprego

Norgine is seeking a Computer Systems Validation Engineer in Hengoed for a 12-month fixed-term contract. You will guide validation of GxP-regulated computerised systems, ensuring data integrity and regulatory compliance across the system lifecycle.

You will develop validation plans, perform testing, support audits and collaborate with Quality, Manufacturing, Engineering and IT teams to embed validation requirements with a risk-based mindset.