Summary
Our client, a pharmaceutical company located in Tipperary, is looking for a CSV Lead who will be responsible for delivering the full validation lifecycle for computerised systems within a large‑scale capital project. This includes developing and maintaining validation documentation, ensuring alignment with project requirements and regulatory expectations, and working collaboratively with internal teams and external integration partners.
Responsibilities
* Act as the CSV SME for the project team and support a consistent validation strategy across all capital workstreams.
* Develop and maintain Qualification Plans, Test Plans and other lifecycle documents, aligned with project Commissioning and Qualification (C&Q) activities.
* Create templates for System Development Lifecycle (SDLC) deliverables to support consistent implementation, including Requirements Specifications, Traceability Matrices, Functional and Design Specifications, Code Review documentation and Test specifications and test scripts.
* Review and approve SDLC documentation, ensuring compliance with project standards and regulatory expectations.
* Provide oversight of Factory Acceptance Testing (FAT) and conduct leveraging assessments where applicable.
* Work closely with Digital, Data and Quality stakeholders to ensure validation requirements are met across all deliverables.
* Support the development of realistic project schedules, trackers and reporting tools.
* Collaborate closely with system suppliers and integration partners to ensure adherence to required standards.
* Participate in project meetings and maintain clear communication across all project stakeholders.
Qualifications & Experience
* Degree in Computer Science, Engineering or a related discipline.
* Minimum 3 years' experience in a CSV role within the life sciences sector.
* Strong knowledge of GAMP 5 and computerised systems validation within regulated manufacturing environments.
* Experience working with automation or data systems within a GMP context.
* Proficient in Microsoft Excel, Word, PowerPoint and SharePoint.
* Experience with paperless validation tools (e.g., Kneat) is beneficial.
* Experience collaborating with vendors or external partners as part of large‑scale projects is advantageous.
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