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System validation engineer

Independent Solutions
Validation engineer
Posted: 11 December
Offer description

Job Title- Computer System Validation (CSV) Engineer – Capital ProjectsMode- HybridDuration- 2 yearsWe are seeking a highly skilledComputer System Validation (CSV) Engineerto play a pivotal role in delivering complex capital projects supporting next-generation manufacturing operations.This is along-term contract opportunity (2 years)within a high-impact digital program, offering outstanding exposure to advanced automation systems, paperless validation, and global regulatory standards.Role Overview:You will leadComputer System Validation activitiesacross major capital projects. You will collaborate withDigital, Automation, IT, and Vendor teams, ensuring systems fully comply withregulatory, data integrity, and GAMP5 standards.Key Responsibilities:Act as the CSV Subject Matter Expert (SME) for capital project teamsDevelop and maintain Qualification Plans, Test Plans, and validation strategiesLead the preparation and control of all SDLC validation deliverables, including:Requirements SpecificationsFunctional & Design SpecificationsRequirements Traceability Matrices (RTM)Code ReviewsTest Specifications & ScriptsEnsure all deliverables comply with global quality and validation standardsProvide FAT oversight and leveraging assessmentsReview and approve all SDLC documentationPartner closely with Digital Data & Quality teams to ensure data integrity complianceSupport project schedules, validation trackers, and documentation controlWork directly with vendors, system integrators, and internal stakeholdersRepresent CSV in automation, IT, and project meetingsExperience, Skills & Qualifications:Mandatory:Minimum 5 years' experience in CSV within Life Sciences / Pharmaceutical Manufacturing.Expert knowledge of GAMP5.Hands-on experience with Emerson DeltaV (essential).Strong experience across SDLC and validation lifecycle.Fluent English – written & verbalProficient in MS Excel, SharePoint, Word & PowerPointDegree in Computer Science, Engineering, or equivalent.Highly AdvantageousExperience with DCS, Siemens PLC/SCADA, OSISoft PI, Werum PAS-XPrevious experience on large capital automation projectsExperience with paperless validation systems (e.g., Kneat)

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