What you need to know: Reporting to the Digital MMD Project Manager and CSV Lead, specifically responsible for Computer System Validation. Your New Job: The CSV engineer will be responsible for the development of key quality documents, such as Quality Assurance (QAPs) test plans, Requirements Traceability Matrices and Quality assurance summary reports, ensuring adherence to company and regulatory standards. Working closely with Digital MMD teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems. Review and ensure vendors compliance with company quality standards. Represent the CSV function at Automation, IT and other project meetings, as required. Key Duties and Responsibilities: Successful candidate will be capable of acting as the CSV SME for the project team and providing a standardised 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 plan and with the leveraging strategy. Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to: o Requirements Specification oRequirements Traceability Matrix oFunctional Specification oDesign Specification oCode Review o Test specification/test script o Etc. Work closely with the Digital Data and Quality (DDQ) function and ensure their requirements are met in all deliverables. Approval of all Digital MMD SDLC deliverables, ensuring compliance with standards Provide FAT oversight and perform leveraging assessments. Provide guidance and support to Digital MMD team members tasked with delivery of SDLC documents. Provide input to the development of realistic project schedules and document trackers. Work closely with suppliers / integrators to ensure compliance with company standards. Participate in, and support, relevant project meetings. Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to Digital MMD validation requirements. What are we looking for? Fluent in English, written and verbal. Minimum of 3 years experience in a similar role in life sciences, ideally in pharmaceutical manufacturing. 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 This is a site based role. The successful candidate may sometimes be required to attend meetings at Vendor premises or other company sites as required. 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 advantageous. Apply for this job now or get in touch with Brenda on By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. We Value Your Trust.