Technical Writer 1710
Posted 2 days 4 hours ago by Simotechnology
Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients' life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.
SimoTech is seeking a TechnicalWriter to support a warehouse digitisation initiative for our biopharma clientin Co. Cork.
In this role, you will support thetransition of warehouse operations from paper-based processes to digitalsystems. You will create and update compliant documentation, support CSVtesting activities, and help ensure all digital workflows meet GxP, data integrity,and regulatory requirements. This is a hands-on role combining technicalwriting, validation support, and process improvement as part of a wider digitaltransformation programme.
- Support CSV testing activities for new warehouse digital systems,including IQ, OQ, PQ, and User Acceptance Testing, ensuring properdocumentation of protocols, scripts, and test results.
- Create, review, and maintain controlled documents to support thetransition from paper-based to digital workflows.
- Develop and standardise new digital SOPs, work instructions, and jobaids to replace existing manual processes.
- Collaborate with IT, Quality, Engineering, and Operations teams tocapture and translate paper-based workflows into validated digital procedures.
- Provide documentation support for change controls, deviations, CAPAs,and lifecycle records related to system implementations.
- Ensure adherence to IT compliance activities, including audit trailreviews, periodic reviews, and lifecycle documentation for new systems.
- Support audit readiness activities and assist SMEs during internal andexternal audits.
- Communicate process and procedural changes effectively to operationalteams and assist in preparing training materials for rollout readiness.
- Monitor compliance and validation deliverables, reporting progress,risks, and gaps during the digitisation initiative.
- Bachelor's degree in Science, Engineering, IT, or a related technicaldiscipline.
- Demonstrated expertise in technical writing and controlleddocumentation, including SOP development and validation documentation.
- Demonstrated understanding of ComputerSystem Validation (CSV) testing within a regulated pharmaceutical or GMPenvironment.
- Understanding of GxP, 21 CFR Part 11, and data integrity requirementsfor computerized systems.
- Experience supporting IT compliance, quality systems, or regulatedmanufacturing environments.
- Familiarity with warehouse digitization projects or systemimplementations (experience with platforms like SAP, Tulip, MES, or WMS isdesirable).
- Strong interpersonal and communication skills with the ability totranslate complex processes into clear, concise documents.
- Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
- Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
- Opportunity towork with large corporate clients