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.
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CSV Engineer- 12 months FTC employer: Norgine B.V.
Norgine B.V. is an excellent employer that fosters a collaborative and innovative work culture, where employees are empowered to make a meaningful impact on product quality and compliance. Located in a dynamic environment, the company offers robust growth opportunities through professional development and training, ensuring that team members can advance their careers while contributing to the success of the Global Quality Team. With a strong commitment to employee well-being and a focus on teamwork, Norgine provides a rewarding workplace for those passionate about quality assurance in the pharmaceutical industry.
