GxP Technical Writer: CSV & Validation for Warehouse

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 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