Description
A Global Pharmaceutical manufacturer based in the North-West is currently looking for an experienced CSV Engineer (Computer Systems Validation) to join the Engineering team on site in line with a continued period of growth.The responsibilities of the CSV Engineer (Computer Systems Validation) are as follows:
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.
Ensure gap analysis has been performed against global computerized system validation policies and issues have been resolved.
Perform Periodic System Reviews, ensuring that the systems maintain their validated status.
Support Regulatory inspections and internal and partner audits and implement corrective actions as needed. Provide CSV related responses to inspectors/auditors.
To fulfil these requirements for the CSV Engineer (Computer Systems Validation) you must have the following skills/experience:
Previous experience working as part of a Computer Systems Validation (CSV) department within the Pharmaceutical/Biopharmaceutical industry with knowledge of FDA and cGMP requirements.
Knowledge of Validation lifecycles 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 (Computer Systems Validation) will have the chance to work in a very reputable company within the Pharmaceutical industry during a very exciting period and receive competitive rates of pay.