Description
A Global Pharmaceutical manufacturer, based in the North-West of the UK, is currently looking for an experienced Computer Systems Validation (CSV) Engineer, to join the Engineering team on site, to assist with a continued period of growth.The responsibilities of the CSV Engineer are as follows:
* Ensure gap analysis has been performed against global computerised system validation policies and issues have been resolved.
* Computer system validation for all manufacturing and related automation systems, including distribution control systems, building automation system, programmable logic controllers (PLCs), utilities control system(s), manufacturing execution systems and automated lab equipment software.
* Maintain and develop current validation procedures, implementing improvements wherever possible.
* Perform Periodic System Reviews, ensuring that the systems maintain their validated status.
* Support the validation activities in conjunction with new projects to include: Facility monitoring systems installation, lab execution systems, BMS and Serialisation.
To fulfil these requirements for the CSV Engineer you must have the following skills/experience:
* Previous experience working as part of a Computer Systems Validation Department within the Pharmaceutical/Bio-pharmaceutical industry, with knowledge of FDA and cGMP requirements.
* Knowledge of validation life-cycles for site systems (e.g. IT, Control Systems, Analytical Equipment, Spreadsheets, etc.)
* Practical experience with quality risk management and risk-based validation approaches and a thorough understanding of industry standards and best practices for computer system validation.
* Educated to degree level/equivalent experience.
* Excellent communication and presentation skills.
The successful CSV Engineer will have the chance to work in a very reputable company within the Pharmaceutical industry during a very exciting period of projects and receive competitive rates of pay.