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.

• 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.

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