{"id":2435588,"url":"https://alion.io/job/paciv-computer-system-validation-csv-engineer-paciv","title":"Computer System Validation (CSV) Engineer - PACIV","company":{"id":4419733,"name":"Paciv","domain":"paciv.com","url":"https://alion.io/company/paciv","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Tipperary, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":65000,"max_usd":112000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":48},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-13T10:35:55Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-13T20:11:59Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Position: Computer System Validation (CSV) Engineer. Location: Munster, Ireland.\nPACIV, a global leader in industrial automation solutions with offices in Ireland, the United States and Puerto Rico, and serving the Life Science, F&B and Utilities industries, is looking for an experienced CSV Engineer. This is a site-based role.Client site Tipperary.\nJob Description\nThis role is a CSV Engineer working within a multinational life science manufacturing environment in Munster. The main focus of the role will be to provide Computer System Validation (CSV) leadership and support for digital manufacturing capital projects, ensuring all automated and computerised systems are implemented, qualified, and validated in compliance with company quality standards, GAMP5, SDLC methodology and all applicable regulatory requirements.\nResponsibilities of the Role\nServe as CSV Subject Matter Expert (SME) for digital manufacturing capital projects. \nProvide a standardised CSV approach across projects in alignment with the CSV Lead's validation strategy. \nWork closely with Automation, IT, Quality, Engineering, and Digital Manufacturing teams responsible for system delivery and implementation. \nCollaborate with vendors, suppliers, and system integrators to ensure compliance with company validation and quality requirements. \nDevelop and maintain Validation Plans, Qualification Plans and Test Plans aligned with project Commissioning & Qualification (C&Q) strategies. \nDevelop, review, and approve Software Development Lifecycle (SDLC) deliverables, includingRequirements Specifications, Functional Specifications, Design Specifications, Requirements Traceability Matrices (RTM), Code Review Documentation, Test Specifications and Test Scripts, Validation Summary Reports, and additional qualification and validation documentation as required.\nEnsure all CSV deliverables comply with company quality procedures, GAMP5 guidance, SDLC requirements and applicable regulatory standards. \nPartner with Digital Data & Quality teams to ensure all data integrity and compliance requirements are addressed. \nReview vendor documentation and validation packages to confirm compliance with company standards and leveraging requirements. \nProvide Factory Acceptance Testing (FAT) oversight and perform validation leveraging assessments. \nSupport project teams with CSV guidance, document generation, review, and execution activities. \nParticipate in project planning activities and provide input into realistic project schedules and validation trackers. \nRepresent the CSV function at project, automation, IT, quality and stakeholder meetings. \nFacilitate communication between project stakeholders regarding validation strategy, documentation, testing, and compliance requirements. \nSupport regulatory inspections, audits and quality reviews as required.\nDeliverables include Computer System Validation Plans (CSV Plans), Qualification Plans and Test Plans, Requirements Specifications (URS/RS), Functional Specifications (FS), Design Specifications (DS), Requirements Traceability Matrices (RTM), Code Review Documentation, Test Specifications and Test Scripts, Validation Summary Reports, FAT Oversight Documentation and Leveraging Assessments, Vendor Compliance Review Reports, SDLC Templates and Validation Documentation Standards, Qualification and Validation Execution Records, Validation Schedules and Document Trackers, Risk Assessments and Compliance Assessments, Audit and Inspection Support Documentation, Project Status Reports and Stakeholder Updates, Final Validation Approval and Project Closeout Documentation.\nRequirements\nMust have a valid EU Work Permit and Irish Residency.\nPlease no Agencies at this time\nQualifications:\nA degree in Engineering, Computer Science, Industrial Automation and Control systems, or equivalent.\nExperience/Skills Required:\n5+ years of experience in Computer System Validation (CSV) within a pharmaceutical manufacturing environment.\nExpert knowledge of GAMP5 validation methodology.\nStrong understanding of SDLC processes and validation lifecycle requirements.\nExperience developing and executing validation documentation within GMP-regulated environments.\nDemonstrated experience reviewing and approving validation deliverables.\nExperience working with vendors and system integrators on regulated projects.\nStrong stakeholder management, communication and technical writing skills.\nAbility to 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