Technical Writer 1710

Simotechnology; Cork; On-site; EUR 52,000 - 78,000; Full time

Benefits offered by this job

Educational support

Career progression

Competitive salary

Job summary

SimoTech in Ireland is recruiting a Technical Writer to support a warehouse digitisation initiative for a biopharma client in Cork. The role combines technical writing, validation support, and process improvement within a broader digital transformation program.

You will develop and maintain compliant documentation, support CSV testing activities, and ensure digital workflows meet GxP, data integrity, and regulatory requirements. Collaboration with IT, Quality, and Operations is essential.

Qualifications

• Bachelor's degree in Science, Engineering, IT, or a related technical discipline.
• Expertise in technical writing and controlled documentation.
• Knowledge of CSV testing within regulated pharma or GMP environments.
• Understanding of GxP, 21 CFR Part 11, and data integrity for computerized systems.
• Experience supporting IT compliance and quality systems.

Responsibilities

• Support CSV testing activities for new warehouse digital systems, including IQ, OQ, PQ, and UAT, documenting results.
• Create, review, and maintain controlled documents supporting digital workflows.
• Develop and standardise SOPs, work instructions, and job aids.
• Collaborate with IT, Quality, Engineering, and Operations to digitize paper workflows.
• Provide documentation support for change controls, deviations, CAPAs, and lifecycle records.
• Ensure IT compliance activities, including audit trails and lifecycle documentation.
• Assist SMEs during internal and external audits.
• Prepare training materials for rollout readiness.
• Monitor validation deliverables, report risks and gaps.

Skills

Technical writing

Controlled documentation

SOP development

Validation documentation

IT compliance awareness

Communication skills

Education

Bachelor's degree in Science, Engineering, IT, or related technical discipline

Tools

SAP

Tulip

MES

WMS

Job description

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.

Technical Writer 1710

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.

Key Responsibilities

• 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.

Requirements

Qualifications &Experience

• 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.
  

What SimoTech CanOffer

• 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