Technical Writer

SimoTech; Munster; On-site; EUR 50,000 - 70,000; Full time

Job summary

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

The role focuses on transitioning from paper to digital systems, creating and updating compliant documentation, and supporting CSV testing activities within a GMP/regulatory framework. You will develop SOPs, work instructions, and training materials, collaborating with IT, Quality, Engineering and Operations to ensure validated digital procedures and lifecycle

Qualifications

• Bachelor's degree in Science, Engineering, IT, or a related technical discipline.
• Minimum 3 years of experience in technical writing and controlled documentation.
• Experience with CSV validation testing in regulated environments.
• Familiarity with GxP and 21 CFR Part 11 data integrity requirements.
• Experience supporting IT compliance or quality systems.
• Exposure to warehouse digitization platforms like SAP, Tulip, MES, or WMS is desirable.

Responsibilities

• Create, review, and maintain controlled documents to support 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 trails and lifecycle documentation, are followed.
• Support audit readiness activities and assist during internal and external audits.
• Communicate process and procedural changes to operational teams and assist in training material rollout readiness.
• Monitor compliance and validation deliverables, reporting progress, risks, and gaps.

Skills

Technical writing

Controlled documentation

SOP development

Validation documentation

CSV testing

Regulatory compliance

GxP knowledge

Data integrity

IT compliance

Stakeholder communication

Education

Bachelor's degree in Science/Engineering/IT or related

Tools

SAP

Tulip

MES

WMS

Job description

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

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.

Key Requirements

• Bachelor’s degree in Science, Engineering, IT, or a related technical discipline.
• Minimum 3 years experience and 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.

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 on exciting capital projects.