Technical Writer - GMP Documentation & Training

Summary:

A Technical Writer is required for a leading biopharmaceutical company based in Cork. The successful candidate will support operations through effective document management and training administration, ensuring documentation is accurate, compliant, and inspection-ready. The role requires strong technical writing skills, excellent organisational abilities, and the ability to coordinate training activities while supporting personnel cross-training. This is a fully site-based role.

Responsibilities:

• Lead, develop, and drive the ongoing enhancement of the documentation management strategy.
• Produce high-quality, accurate documentation by applying data integrity and ALCOA principles, adhering to compliance best practices, and ensuring all materials are appropriate for their intended audience.
• Serve as Subject Matter Expert (SME) for Veeva Quality Documents & Compliance Wire, offering guidance and support to colleagues in the use of these systems.
• Draft, review, and approve BPDs, SOPs, technical protocols & reports, forms, work instructions, and other document types.
• Collaborate closely with technical SMEs and teams to gain deep business and product knowledge for accurate documentation requirements.
• Demonstrate excellent verbal and written communication skills to engage and motivate diverse audiences.
• Propose and implement continuous improvements to the technical writing process, such as developing Advanced Templates.
• Support Technical Writing activities across the site and collaborate with various departmental SMEs.
• Manage the transition of documentation into Veeva Quality Documents and initiate Change Requests as necessary.
• Support Global Training &/or Bus Ops with BcoE training development programs and materials, guides, and e-learning modules to address identified learning requirements.

Qualifications & Experience:

• Third level qualification in a Science or an Engineering discipline, and/or extensive related proven experience in the required areas: technical document writing.
• 3+ years’ experience in technical document writing within a regulated environment.