Job DescriptionOverview• Reporting to the Digital Project Manager and CSV Lead, this role is specifically responsible for Computer System Validation (CSV).• The CSV Engineer will develop key quality documents such as Quality Assurance Plans (QAPs), test plans, Requirements Traceability Matrices, and Quality Assurance Summary Reports, ensuring adherence to internal and regulatory standards.• The role requires close collaboration with Digital teams responsible for Automation and IT, as well as with vendors and partners delivering systems.• The CSV Engineer will review vendor documentation and ensure compliance with applicable quality standards.• The successful candidate will represent the CSV function at Automation, IT, and cross-functional project meetings, as required.Role Functions(Functions include, but are not limited to, the following)• Act as the CSV subject matter expert (SME) for the project team, 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 strategy.• Develop templates for all SDLC deliverables to ensure consistent implementation of the validation strategy, including but not limited to:Requirements SpecificationRequirements Traceability MatrixFunctional SpecificationDesign SpecificationCode ReviewTest Specifications/Test ScriptsAdditional SDLC documentation as neededWork closely with Digital Data and Quality (DDQ) teams to ensure all requirements are incorporated into project deliverables.Approve all Digital SDLC deliverables, ensuring compliance with defined standards.Provide FAT oversight and conduct leveraging assessments.Guide and support Digital team members responsible for producing SDLC documents.Contribute to the development of project schedules and document trackers.Collaborate closely with suppliers and system integrators to ensure adherence to quality and validation standards.Participate in and support project meetings.Liaise with project stakeholders to ensure clear communication regarding validation requirements.Knowledge, Skills, and Education Requirements• Fluent in English, both written and verbal.• Minimum of 3 years' experience in a similar role within the life sciences sector, preferably pharmaceutical manufacturing.• Expert knowledge of GAMP 5.• Essential experience with Emerson DeltaV.• Additional experience with the following systems would be advantageous: DCS, Siemens PLC/SCADA, OSISoft PI, Werum PAS-X.• This is a site-based role; occasional travel to vendor premises or other company sites may be required.• Strong computer skills, proficient in Microsoft Excel, SharePoint, Word, and PowerPoint.• Strong interpersonal and communication skills (both verbal and written).• Degree in Computer Science, Engineering, or a related discipline (or equivalent experience).• Experience working with paperless validation systems such as Kneat is advantageous.• Previous experience with large-scale pharmaceutical digital or automation projects is beneficial.