Technical Writer

About SimoTech

SimoTech specialises in manufacturing automation and IT systems engineering, offering project management and validation services to life sciences companies. Our collaboration helps design, construct, operate, and optimize critical process automation systems that accelerate project delivery, enhance operational efficiency, boost manufacturing flexibility, and ensure regulatory compliance.

Work Culture and Benefits

At SimoTech, a culture rooted in collaboration, respect, trust, and excellence prevails. We play a vital role in supporting clients’ delivery of life-changing products to patients. Our employees enjoy competitive salaries, career advancement opportunities, educational support, and various additional benefits.

Job Overview

We are seeking a Technical Writer based in County Cork to assist a biopharmaceutical client with their warehouse digitisation project. The position involves transitioning warehouse operations from manual paper-based methods to digital platforms. Responsibilities include preparing and revising compliant documentation, facilitating Computer System Validation (CSV) testing, and ensuring digital workflows adhere to GxP, data integrity, and regulatory standards. This role combines technical writing skills, validation support, and process enhancement within a broad digital transformation effort.

Key Responsibilities

• Assist with CSV testing for new warehouse digital solutions, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT), ensuring thorough documentation of protocols, test scripts, and results.
• Prepare, review, and maintain controlled documentation to enable the shift from manual to digital workflows.
• Create and standardize digital Standard Operating Procedures (SOPs), work instructions, and job aids replacing traditional manual processes.
• Work collaboratively with IT, Quality, Engineering, and Operations units to convert paper-based processes into validated digital procedures.
• Provide documentation support relating to change controls, deviations, Corrective and Preventive Actions (CAPAs), and lifecycle records linked to system implementations.
• Ensure compliance with IT regulations, including audit trail evaluation, periodic reviews, and documentation lifecycle management for new systems.
• Support audit preparedness and assist Subject Matter Experts (SMEs) during internal and external audits.
• Communicate procedural updates clearly to operational teams and help prepare training resources for system rollout readiness.
• Track compliance and validation deliverables, reporting ongoing progress, risks, and any gaps encountered during the digitisation initiative.

Candidate Requirements

• Bachelor’s degree in Science, Engineering, Information Technology, or a related technical field.
• Proven experience in technical writing with expertise in controlled documentation, including SOP creation and validation documentation.
• In-depth knowledge of Computer System Validation (CSV) testing within regulated pharmaceutical or Good Manufacturing Practice (GMP) environments.
• Familiarity with regulatory requirements such as GxP, 21 CFR Part 11, and data integrity standards for computerized systems.
• Experience supporting IT compliance, quality assurance systems, or working within regulated manufacturing settings.
• Exposure to warehouse digitisation or system implementation projects, with advantageous knowledge of platforms like SAP, Tulip, MES, or Warehouse Management Systems (WMS).
• Excellent communication and interpersonal skills, with the ability to simplify complex workflows into clear, concise documentation.

What We Offer

• A role offering a high level of autonomy, empowering the chosen candidate to realize their capabilities fully.
• Opportunities to develop new technical skills by engaging with emerging technologies within a multidisciplinary environment.
• The chance to collaborate on significant capital projects with major corporate clients.