Norgine is a European specialist pharmaceutical company with a history dating back to 1906. Its team acquires, develops, and commercializes medicines through a global network of partnerships, with particular expertise in gastroenterology and hepatology. The company’s products reach around 25 million patients worldwide each year, supported by more than 1,400 employees and over €500 million in net product sales. Norgine works with partners through licensing, acquisitions, and special purpose vehicles, while reinvesting in the development of future medicines.
Computer Systems Validation Engineer (12-Month Contract) at Norgine
Support validation of Norgine’s regulated computer systems, helping maintain GxP compliance and data integrity. Apply risk-based validation practices across systems and their lifecycle.
Description
- Plan and deliver validation for new and existing GxP-regulated computerised systems.
- Prepare and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
- Test and verify systems against business, quality and regulatory requirements.
- Provide validation evidence for audits, inspections and regulatory enquiries.
- Partner with Quality, Manufacturing, Engineering, IT and vendors to assess changes and incorporate validation throughout the system lifecycle.
- Improve validation standards, processes and practices.
- Help maintain compliance of Norgine’s regulated systems, equipment, validation records and related processes with applicable quality and regulatory requirements.
- Provide lifecycle validation expertise and use risk-based methods to support compliance, data integrity and operational effectiveness.
Requirements
- Bachelor’s degree or equivalent qualification or experience in computer systems, engineering or a related field.
- Experience using relevant procedures or systems.
- Skills in quality assurance methods, review and reporting, data collection and analysis, planning, requirements verification and project quality management.
- Ability to interpret complex information, make sound decisions and determine appropriate actions.
- Strong communication and teamwork skills, including confidence to raise compliance concerns when needed.
- A structured and accountable approach to documentation, testing and delivery.
- Working knowledge of GxP and data integrity principles, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11 guidance.
- Experience preparing and executing validation documents such as risk assessments, protocols, test scripts and validation reports.
- Familiarity with regulated computerised systems in manufacturing, laboratories, quality, ERP, MES or LIMS.
Benefits
- Ongoing professional development in a supportive, inclusive workplace.
- Career development opportunities.
- Work that contributes to improving patients’ lives.
- Benefits vary by location; ask the Norgine Talent Acquisition representative for details.