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.
The ideal candidate will act as the CSV subject matter expert for the project, driving a standardised validation approach and ensuring all deliverables meet required quality standards.
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 5 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.