Technical Writer/CSV Engineer (471)
On-siteCork, Munster, Ireland
Job Summary
Support CSV testing activities (IQ/OQ/PQ, User Acceptance Testing) for new digital systems such as SAP and Tulip, ensuring test scripts, protocols, and results are accurately documented and executed. Create, review, update, and manage controlled documents within document management systems to drive the paper-to-digital transition in warehouse operations. Develop and standardize new digital SOPs, work instructions, and job aids to replace existing paper-based procedures. Partner with IT, Quality, Engineering, and Warehouse Operations teams to capture current-state processes and translate them into clear, validated digital workflows. Provide technical writing support for change controls, deviations, CAPAs, and system lifecycle documentation while championing data integrity principles. Communicate process and procedural changes clearly to staff, supporting training material development and rollout readiness. This initial 9-month contract offers potential for extensions within a regulated pharmaceutical environment.
Required Qualifications
- Demonstrated experience in Computer System Validation (CSV) testing within a pharmaceutical, GMP, or other regulated environment
- Experience in technical writing and documentation within a pharmaceutical, GMP, or regulated environment
- Strong understanding of controlled documentation, change management, and document management processes
- Solid working knowledge of CSV testing methodology and documentation (test scripts, protocols, deviation/discrepancy handling)
- Strong technical writing and communication skills, with the ability to convert complex or manual processes into clear digital procedures
- Ability to interpret operational and technical information and translate it into clear, standardized procedures
- Strong organisational skills with the ability to manage multiple documents, tests, and priorities within a fixed project timeline
- Ability to work independently and collaboratively across cross-functional teams, including warehouse operations staff
- Proactive approach with strong problem-solving skills and comfort working through ambiguity during a transition project
- Strong computer skills and confidence working with document management systems and digital platforms such as SAP and/or Tulip
Desired Qualifications
- Relevant third-level qualification in Science, Engineering, IT, or a related discipline preferred
- Experience supporting IT compliance, quality systems, or manufacturing/warehouse operations desirable
- Prior exposure to system implementations or digitization projects (e.g., SAP, Tulip, MES, WMS) is highly advantageous
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