Technical Writer 1710

Why SimoTech

What
is it like to work at SimoTech? With a strong collaborative teamwork
culture based on respect, trust, and excellence, we play a critical
partnering role to our clients’ life-changing supply of products to
patients.  In return, there is excellent salary, benefits, career
progression, educational support and much more.

Technical Writer 1710

SimoTech is seeking a Technical
Writer to support a warehouse digitisation initiative for our biopharma client
in Co. Cork.

In this role, you will support the
transition of warehouse operations from paper-based processes to digital
systems. You will create and update compliant documentation, support CSV
testing activities, and help ensure all digital workflows meet GxP, data integrity,
and regulatory requirements. This is a hands-on role combining technical
writing, validation support, and process improvement as part of a wider digital
transformation programme.

Key Responsibilities

• Support CSV testing activities for new warehouse digital systems,
  including IQ, OQ, PQ, and User Acceptance Testing, ensuring 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 to replace existing manual processes.
  
• Collaborate with IT, Quality, Engineering, and Operations teams to
  capture 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 trail
  reviews, periodic reviews, and lifecycle documentation for new systems.
  
• Support audit readiness activities and assist SMEs during internal and
  external audits.
  
• Communicate process and procedural changes effectively to operational
  teams and assist in preparing training materials for rollout readiness.
  
• Monitor compliance and validation deliverables, reporting progress,
  risks, and gaps during the digitisation initiative.
  
  
  

Requirements

Qualifications &
Experience

• Bachelor’s degree in Science, Engineering, IT, or a related technical
  discipline.
  
• Demonstrated expertise in technical writing and controlled
  documentation, including SOP development and validation documentation.
  
• Demonstrated understanding of Computer
  System Validation (CSV) testing within a regulated pharmaceutical or GMP
  environment.
  
• Understanding of GxP, 21 CFR Part 11, and data integrity requirements
  for computerized systems.
  
• Experience supporting IT compliance, quality systems, or regulated
  manufacturing environments.
  
• Familiarity with warehouse digitization projects or system
  implementations (experience with platforms like SAP, Tulip, MES, or WMS is
  desirable).
  
• Strong interpersonal and communication skills with the ability to
  translate complex processes into clear, concise documents.
  

Benefits

What SimoTech Can
Offer

• Role provides a
  high degree of autonomy to allow the successful
  candidate to reach their full
  potential.
  
• Develop new
  skills and enhance technical ability by working with
  innovative technologies in a multi- disciplined
  environment.
  
• Opportunity to
  work with large corporate clients