• Reporting to the Project Manager and CSV Lead, specifically responsible for ComputerSystem Validation.• The CSV engineer will be responsible for the development of key quality documents, such as QualityAssurance (QAPs) test plans, Requirements Traceability Matrices and Quality assurance summaryreports, ensuring adherence to regulatory standards.• Will be required to work closely with teams responsible for the full Automation and ITscope and with vendors / partners with responsibility for delivery of systems.• Will review and ensure vendors compliance with quality standards.• Will represent the CSV function at Automation, IT and other project meetings, as required.Successful candidate will be capable of acting as the CSV SME for the project team and providing astandardized CSV approach across capital projects, as defined by the CSV lead.• Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q planand with the leveraging strategy• Develop templates for all SDLC deliverables, compliant with MSD standards, to ensure consistentimplementation of the validation strategy, including but not limited to:o Requirements Specificationo Requirements Traceability Matrixo Functional Specificationo Design Specificationo Code Reviewo Test specification/test scripto Etc.• Work closely with the Digital Data and Quality (DDQ) function and ensure their requirements are metin all deliverables• Approval of all SDLC deliverables, ensuring compliance with standards• Provide FAT oversight and perform leveraging assessments• Provide guidance and support to team members tasked with delivery of SDLCdocuments• Provide input to the development of realistic project schedules and document trackers• Work closely with suppliers / integrators to ensure compliance with MSD standards• Participate in, and support, relevant project meetings• Liaise with the various stakeholders on the overall project to ensure clear communication between allparties in relation to validation requirementsMinimum of 3 years' experience in a similar role in life sciences, ideally in pharmaceuticalmanufacturing.• Expert knowledge of GAMP5.• Experience in the following systems is essential; Emerson DeltaV• Experience in the following systems would be advantageous; DCS, Siemens PLC/SCADA, OSISoft PI, Werum Pax-X• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint,Word and PowerPoint.• Strong interpersonal and communication skills (verbal and written).• Relevant Computer Science or Engineering degree or equivalent• Previous experience working with paperless validation systems (Kneat) will be advantageousGet in touch with George at - if interested in this position.