Computer System Validation (CSV) Engineer
📍 Location: Surrey | 💼 Contract | 🏭 Pharmaceutical Manufacturing
We are on the hunt for Computer System Validation (CSV) Engineer to join our client for an exciting capital project involving a new production line. This role is critical in ensuring that all computerised systems are validated, compliant, and operate reliably in accordance with GxP and industry regulations.
You will be working with a variety of systems, including Sartorius and SAP alongside other GxP-regulated systems within a manufacturing environment.
Key Responsibilities
* Validation Protocols: Develop and execute IQ, OQ, and PQ protocols across a range of systems.
* Documentation: Prepare and maintain validation documentation, including plans, test scripts, traceability matrices, and summary reports.
* Risk Management: Perform risk assessments and impact analyses to identify critical functionalities and vulnerabilities.
* Change Control: Assess system changes and ensure appropriate validation activities are undertaken.
* Regulatory Support: Support audits and inspections by providing documentation and expert input on CSV processes.
What You Need:
* Degree in Science, Engineering, IT or related discipline, or equivalent practical experience.
* Strong knowledge of cGMP, GAMP 5 and relevant regulatory requirements.
* Experience with validation in pharma, biotech, or medical devices.
* Familiarity with systems such as Sartorius and SAP