Digitalization & Validation Technical Writer

Simotechnology

Cork

On-site

EUR 52,000 - 78,000

Full time

14 days+

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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.