We are a rapidly growing company that needs highly motivated people to help drive it forward. We are currently looking to recruit an experienced CSV Engineer to join our team at a Client Site in Leinster.
Computer System Validation Support
This Computer System Validation Support analystis an essential resource responsible for a broad spectrum of SAP CSV (computer System Validation) and support activities. The CSV support analyst will be responsible for the re-qualification of the SAP System and provide validation support to the deployment of the roll out of the OTC module at the site
· Accountable for the execution, completion and tracking of computer system validation documentation to the required MErch SDLC standards.
· Drafting and reviewing of validation documentation and procedures.
· Actively contribute to project teams.
· Performing documentation review to support the EPM (Enterprise Process Management) team.
· System Support – Assists in the maintenance of SAP fields and hardware used for the SAP system
· Continuous Improvement – Keeps abreast of current CSV general knowledge, procedures and business issues in order to facilitate effective and practical solutions to client requests, concerns and inquiries.
Computer system validation experience in vaccine or sterile product manufacturing would be an advantage (min 3 – 5 years) Experience in IMB/FDA environment advantageous. Strong technical writing and communication skills Must be goal-oriented and able to manage risks. Project management skills SAP experience desirable Knowledge of Sigma/Lean principles would be an advantage Proficient in the use of personal computers and business software
· Diploma / BSc associated degree in IT, Business, Engineering, Science or related field
Enterprise System Partners (ESP) is a global project engineering company, with its European headquarters in Ireland and North American headquarters in Massachusetts. We have a proven track record in delivery of IT Manufacturing Solutions to the life sciences industry. We provide systems support for the planning, vendor selection, design and implementation of systems for the entire manufacturing landscape from the automation layer (DCS, SCADA) right up to the ERP layer (e.g. SAP, JD Edwards) with particular expertise in manufacturing and laboratory systems. ESP offers consulting and engineering services including support for the entire life cycle of systems, products, and projects.
Our unique strength is our people collectively understand the entire system landscape within the manufacturing environment. This includes expertise in Manufacturing Execution Systems (MES), (including document management systems, maintenance/calibration systems, CAPA systems, Material Tracking Systems, Electronic Batch Records and W&D) and integration of these systems throughout the entire systems landscape.