Technical Writer

About SimoTech

SimoTech specialises in manufacturing automation, IT systems engineering, project management, and validation services, partnering with life sciences companies to design, implement, and optimize critical process automation systems. These systems aim to accelerate project delivery, improve operational efficiency, increase manufacturing flexibility, and ensure regulatory compliance.

At SimoTech, employees experience a collaborative culture rooted in respect, trust, and excellence. The company plays a pivotal role in supporting clients that deliver essential products to patients, while offering competitive compensation, career advancement, educational support, and other benefits.

Role Overview

We are currently seeking a Technical Writer to assist a biopharma client's warehouse digitisation project in County Cork. This position focuses on transitioning warehouse processes from paper-based methods to digital systems through the creation and maintenance of compliant documentation, CSV testing support, and process improvements within a broader digital transformation initiative. The role blends hands-on technical writing, validation assistance, and process optimization.

Key Responsibilities

• Assist with Computer System Validation (CSV) testing for new digital warehouse systems including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT), ensuring all protocols, test scripts, and results are properly documented.
• Develop, review, and update controlled documentation supporting the shift from manual to digital workflows.
• Create and standardize new Standard Operating Procedures (SOPs), work instructions, and job aids to replace existing manual processes.
• Work collaboratively with IT, Quality, Engineering, and Operations teams to translate paper-based workflows into validated digital procedures.
• Provide documentation support for change controls, deviations, Corrective and Preventive Actions (CAPAs), and system lifecycle records related to implementation activities.
• Ensure compliance with IT requirements such as audit trail reviews, periodic assessments, and lifecycle documentation for deployed systems.
• Support audit preparations and assist Subject Matter Experts (SMEs) during internal and external audits.
• Effectively communicate procedural and process changes to operational teams and help develop training materials for system launches.
• Monitor compliance status and validation deliverables, reporting on progress, risks, and any gaps related to the digitisation efforts.

Candidate Requirements

• Bachelor’s degree in Science, Engineering, Information Technology, or a related technical field.
• At least 3 years of experience proficient in technical writing and managing controlled documents, including SOP creation and validation documentation.
• Solid understanding of Computer System Validation (CSV) processes within regulated pharmaceutical or Good Manufacturing Practice (GMP) contexts.
• Knowledge of GxP regulations, 21 CFR Part 11, and data integrity standards applicable to computerized systems.
• Experience supporting IT compliance, quality management systems, or working within regulated manufacturing environments.
• Familiarity with warehouse digitization projects or system rollouts, with preference for experience using platforms such as SAP, Tulip, Manufacturing Execution Systems (MES), or Warehouse Management Systems (WMS).
• Strong communication and interpersonal skills to clearly simplify complex operational processes into usable documentation.

What SimoTech Offers

• A role offering considerable independence to maximize the candidate’s potential.
• Opportunities for professional growth by engaging with innovative technologies in a multidisciplinary setting.
• Chance to collaborate with major corporate clients on significant capital projects.