PACIV
Computer System Validation (CSV) Engineer
PACIV Ireland - Tipperary, Ireland - Full Time
Position: Computer System Validation (CSV) Engineer. Location: Munster, Ireland.
PACIV, 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.
Job Description
This 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.
Responsibilities of the Role
Requirements
Must have a valid EU Work Permit and Irish Residency.
Please no Agencies at this time
Qualifications:
Experience/Skills Required:
Experience/Skills Desired:
PACIV, 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.
Job Description
This 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.
Responsibilities of the Role
- Serve as CSV Subject Matter Expert (SME) for digital manufacturing capital projects.
- Provide a standardised CSV approach across projects in alignment with the CSV Lead's validation strategy.
- Work closely with Automation, IT, Quality, Engineering, and Digital Manufacturing teams responsible for system delivery and implementation.
- Collaborate with vendors, suppliers, and system integrators to ensure compliance with company validation and quality requirements.
- Develop and maintain Validation Plans, Qualification Plans and Test Plans aligned with project Commissioning & Qualification (C&Q) strategies.
- Develop, review, and approve Software Development Lifecycle (SDLC) deliverables, including Requirements 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.
- Ensure all CSV deliverables comply with company quality procedures, GAMP5 guidance, SDLC requirements and applicable regulatory standards.
- Partner with Digital Data & Quality teams to ensure all data integrity and compliance requirements are addressed.
- Review vendor documentation and validation packages to confirm compliance with company standards and leveraging requirements.
- Provide Factory Acceptance Testing (FAT) oversight and perform validation leveraging assessments.
- Support project teams with CSV guidance, document generation, review, and execution activities.
- Participate in project planning activities and provide input into realistic project schedules and validation trackers.
- Represent the CSV function at project, automation, IT, quality and stakeholder meetings.
- Facilitate communication between project stakeholders regarding validation strategy, documentation, testing, and compliance requirements.
- Support regulatory inspections, audits and quality reviews as required.
- Deliverables 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.
Requirements
Must have a valid EU Work Permit and Irish Residency.
Please no Agencies at this time
Qualifications:
- A degree in Engineering, Computer Science, Industrial Automation and Control systems, or equivalent.
Experience/Skills Required:
- 5+ years of experience in Computer System Validation (CSV) within a pharmaceutical manufacturing environment.
- Expert knowledge of GAMP5 validation methodology.
- Strong understanding of SDLC processes and validation lifecycle requirements.
- Experience developing and executing validation documentation within GMP-regulated environments.
- Demonstrated experience reviewing and approving validation deliverables.
- Experience working with vendors and system integrators on regulated projects.
- Strong stakeholder management, communication and technical writing skills.
- Ability to operate effectively within cross-functional project teams.
Experience/Skills Desired:
- Experience with Kneat eVal system.
