Technical Writer - Shabally, Cork

RECRUITERS; Cork; On-site; EUR 45,000 - 68,000; Full time

Job summary

RECRUITERS is seeking an experienced Technical Writer for a leading biopharmaceutical organisation in Ireland. You 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.

You will lead documentation strategy, draft and approve SOPs and technical protocols, ensure ALCOA data integrity, and act as SME for Veeva Quality Documents and

Qualifications

• Third-level qualification in a Science or Engineering discipline, or equivalent experience.
• Proven experience in technical writing and controlled documentation in regulated environments.
• Strong understanding of GxP, regulatory compliance, data integrity and ALCOA.
• Experience with document management or quality systems like Veeva or ComplianceWire.

Responsibilities

• Lead and enhance the site's documentation management strategy.
• Develop, draft, review and approve SOPs, reports and work instructions.
• Ensure documents meet ALCOA, data integrity and regulatory requirements.
• Act as SME for Veeva Quality Documents and ComplianceWire.
• Collaborate with SMEs and cross-functional teams to translate requirements into documentation.
• Support training development with materials and e-learning content.

Skills

Technical writing

Compliance awareness

Communication skills

Education

Science or Engineering degree

Tools

Veeva Quality Documents

ComplianceWire

Job description

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.