SimoTech is seeking a Technical Writer to support a warehouse digitisation initiative for our biopharma client in Cork, Ireland. The role focuses on transitioning warehouse operations from paper-based processes to digital systems, creating and updating compliant documentation, supporting CSV testing activities, and ensuring digital workflows meet GxP, data integrity, and regulatory requirements. This hands-on position combines technical writing, validation support, and process improvement as part of a broader digital transformation programme.

Key responsibilities: - Support CSV testing activities for new warehouse digital systems, including IQ, OQ, PQ, and User Acceptance Testing, with proper documentation of protocols, scripts, and test results - Create, review, and maintain controlled documents to support the transition from paper-based to digital workflows - Develop and standardise new digital SOPs, work instructions, and job aids - Collaborate with IT, Quality, Engineering and Operations to translate paper-based workflows into validated digital procedures - Provide documentation support for change controls, deviations, CAPAs, and lifecycle records - Ensure IT compliance activities, including audit trail reviews, periodic reviews, and lifecycle documentation for new systems - Support audit readiness activities and assist SMEs during internal and external audits - Communicate changes effectively to operational teams and assist in training materials for rollout readiness - Monitor compliance and validation deliverables, reporting progress, risks and gaps in the digitisati

SimoTech is seeking a Technical Writer to support a warehouse digitisation initiative for our biopharma client in Cork, Ireland. The role focuses on transitioning warehouse operations from paper-based processes to digital systems, creating and updating compliant documentation, supporting CSV testing activities, and ensuring digital workflows meet GxP, data integrity, and regulatory requirements. This hands-on position combines technical writing, validation support, and process improvement as part of a broader digital transformation programme.

Key responsibilities: - Support CSV testing activities for new warehouse digital systems, including IQ, OQ, PQ, and User Acceptance Testing, with proper documentation of protocols, scripts, and test results - Create, review, and maintain controlled documents to support the transition from paper-based to digital workflows - Develop and standardise new digital SOPs, work instructions, and job aids - Collaborate with IT, Quality, Engineering and Operations to translate paper-based workflows into validated digital procedures - Provide documentation support for change controls, deviations, CAPAs, and lifecycle records - Ensure IT compliance activities, including audit trail reviews, periodic reviews, and lifecycle documentation for new systems - Support audit readiness activities and assist SMEs during internal and external audits - Communicate changes effectively to operational teams and assist in training materials for rollout readiness - Monitor compliance and validation deliverables, reporting progress, risks and gaps in the digitisati