Réalta Technologies

Technical Writer/CSV Engineer (471)

Réalta Technologies  •  Cork, IE (Onsite)  •  16 hours ago
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Job Description

 Réalta Technologies are searching for a Technical Writer/CSV Engineer to support our Pharmaceutical client based in Cork.
The successful candidate will be focused on eliminating paper-based processes in warehouse operations and transitioning to digital workflows. This role will be central to Computer System Validation (CSV) testing, and to documenting, standardizing, and communicating new digital procedures as the site rolls out and integrates systems such as SAP and Tulip, alongside other supporting technologies, to replace manual and paper-driven tasks.
The successful candidate will ensure documentation and testing deliverables meet regulatory, corporate, and site requirements while supporting a smooth transition to digital warehouse operations in a regulated pharmaceutical environment.
 
This role will be offered on an initial 9-month contract, with the potential for extensions to follow.
 
Job Responsibilities
  • 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 in support of the paper-to-digital transition.
  • Develop and standardize new digital SOPs, work instructions, and job aids to replace existing paper-based warehouse procedures.
  • Partner with IT, Quality, Engineering, and Warehouse Operations teams to capture current-state (paper) processes and translate them into clear, validated digital procedures.
  • Provide technical writing support for change controls, deviations, CAPAs, and system lifecycle documentation associated with the digitization initiative.
  • Support IT compliance activities, including System Periodic Reviews, Audit Trail Reviews, and validation lifecycle documentation for newly implemented systems.
  • Communicate process and procedural changes clearly to warehouse operations staff, supporting training material development and rollout readiness.
  • Champion data integrity principles and ensure new digital workflows and IT procedures align with regulatory and corporate requirements.
  • Support audit readiness activities and assist SMEs during internal and external audits related to the digitized processes.
  • Track and report project and compliance metrics, flagging risks or gaps in documentation and testing coverage as the initiative progresses.
Job Requirements
  • Relevant third-level qualification in Science, Engineering, IT, or a related discipline preferred.
  • 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.
  • 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.
  • Strong understanding of controlled documentation, change management, and document management processes.
  • Strong technical writing and communication skills, with the ability to convert complex or manual processes into clear digital procedures.
  • Solid working knowledge of CSV testing methodology and documentation (test scripts, protocols, deviation/discrepancy handling).
  • Excellent attention to detail and commitment to right-first-time documentation and testing.
  • 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
Réalta Technologies

About Réalta Technologies

Réalta Technologies is a Global Automation, Digital Systems and Data Analytics Company Headquartered in Cork, Ireland. From our offices in Ireland, the US and India, we provide world-class services and solutions to our clients all over the world.

We specialize in automation, process optimization, data-intelligence and data-driven technology solutions for businesses. We work with clients across many sectors, such as Pharma, Bio-Pharma, Med Device, FMCG, manufacturing and professional sports sectors.

Our team has broad knowledge and expertise across a wide range of technologies, platforms, and systems. This includes Engineering, Industrial Automation, IT Systems, Data Historians, Data Analytics and Consultancy.

We are an AVEVA endorsed system integrator who specialise in the delivery of advanced PI System solutions, as well as new PI system implementations, PI system expansions and 24/7 system support.

We are proud to be the Official Data Solutions Partner of Munster Rugby.

Industry
IT & Software
Company Size
51-200 employees
Headquarters
Ballincollig, IE
Year Founded
2017
Website
realtatechnologies.com
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