CSV Engineer- 12 months FTC

Norgine B.V.; Cefn Hengoed; Presencial; GBP 45.000 - 65.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GxP validation

Risk-based approach

Quality assurance

Documentation

Communication

Educación

Bachelor's in computer systems

Descripción del empleo

In this role, you will help ensure that Norgine's GxP-regulated computerised systems, equipment, validation documentation and associated processes meet applicable quality and regulatory requirements. You will provide practical validation expertise throughout the system lifecycle and apply risk-based principles to support compliance, data integrity and operational effectiveness.,

• 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.
• Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.
• A bachelor's degree, or equivalent qualification or experience, in computer systems, engineering or a related discipline.
• Experience working with relevant procedures or systems.
• Competence in quality assurance methodologies, review and reporting, data collection and analysis, planning and organisation, requirements verification and project quality management.
• Ability to interpret complex information, make sound decisions and identify appropriate actions.
• Strong collaboration and communication skills, with the confidence to raise compliance concerns when required.
• A structured, accountable approach to documentation, testing and delivery.

Beneficial experience

• Working knowledge of GxP requirements, data-integrity principles and relevant guidance, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
• Experience producing and executing validation deliverables, including risk assessments, protocols, test scripts and validation reports.
• Familiarity with manufacturing, laboratory, quality, ERP, MES, LIMS or other regulated computerised systems.

Bring our values to life

• Drive: Take ownership, focus on business priorities and deliver results.
• Dare: Challenge respectfully, explore new ideas and address difficult issues constructively.
• Develop: Build strong connections, collaborate across teams and value different perspectives.

At Norgine, you'll join an inclusive environment where different perspectives are valued. You'll have opportunities to develop your career while contributing to work that makes a meaningful difference to patients' lives.