Technical Writer - Shabally, Cork

Technical Writer

Contract: 12 months

Location: Shanbally, Cork

Working arrangement: Fully onsite

Hours: 8:30am–5:00pm

A leading biopharmaceutical organisation is seeking an experienced Technical Writer. The role will support laboratory operations through high-quality technical documentation, document management and training coordination, with a strong focus on regulatory compliance, data integrity and inspection readiness.

Key Responsibilities

• Lead and continuously enhance the site’s documentation management strategy and technical writing processes.
• Develop, draft, review and approve a range of controlled documents, including SOPs, BPDs, technical protocols, reports, forms and work instructions.
• Ensure documentation meets data integrity, ALCOA principles and regulatory compliance requirements, while remaining appropriate for its intended audience.
• Act as a Subject Matter Expert (SME) for Veeva Quality Documents and ComplianceWire, providing guidance and support to colleagues.
• Work closely with technical SMEs and cross-functional teams to understand business and product requirements and translate them into accurate, effective documentation.
• Manage the transition of documentation into Veeva Quality Documents and initiate Change Requests where required.
• Identify and implement continuous improvements to technical writing processes, including the development of advanced templates and improved documentation practices.
• Support training development programmes by creating training materials, guides and e-learning content, while collaborating with Global Training and Business Operations teams.

Requirements

• Third-level qualification in a Science or Engineering discipline, or extensive relevant experience in technical document writing.
• Proven experience in technical writing and controlled documentation, ideally within a pharmaceutical, biotechnology, laboratory or regulated environment.
• Strong understanding of GxP, regulatory compliance, data integrity and ALCOA principles.
• Experience working with document management or quality systems, ideally Veeva Quality Documents and/or ComplianceWire.
• Excellent written and verbal communication skills, with the ability to work effectively with technical SMEs and diverse stakeholders.
• Highly organised, self-motivated and able to work independently while managing multiple priorities in a regulated environment.

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