Job Description

Team Horizon is seeking a Technical Writer for our client in Dublin. As a Technical writer you will be responsible for updating and creation of new technical procedures and SOPs for new equipment and equipment upgrades. Hybrid working available.

Why you should apply:

* You enjoy working on exciting projects and want to work with a global manufacturing site in Dublin.

* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

* Generous rates and flexible working hours

What you will be doing:

* Write and update technical documentation for Equipment Projects and Validation teams, including validation protocols, reports, and equipment specifications.

* Develop and maintain documentation for new equipment installations and equipment upgrades, ensuring all relevant procedures are clearly documented.

* Create and update Standard Operating Procedures (SOPs) for new equipment and equipment upgrades, ensuring documentation is accurate and meets regulatory requirements.

* Revise and maintain technical procedures to reflect changes in equipment functionality, process improvements, or new regulations.:

* Familiarize yourself with D2 file storage and collaboration repositories (or similar document management systems) for storing, sharing, and version-controlling documents.

* Ensure that all documentation is properly organized, stored, and accessible by relevant stakeholders in a structured, auditable manner.:

* Gain a thorough understanding of Oral Solid Dosage (OSD) manufacturing equipment, including tablet presses, granulators, blenders, and other related machinery.

* Document operating procedures, troubleshooting guides, and maintenance instructions for OSD equipment.

* Develop and update documentation for packaging equipment, including blister pack lines, bottle filling lines, sachet lines, and serialisation systems.

* Ensure that documentation for packaging equipment meets regulatory standards for serialization and traceability.

* Apply engineering and pharmaceutical knowledge to produce technical documentation that aligns with Good Manufacturing Practices (GMP).

* Ensure that documentation is suitable for a GMP environment, including validation reports, qualification protocols, and equipment calibration records.

* Develop and update documentation related to GMP equipment cleaning procedures, ensuring compliance with regulatory guidelines.

* Write and revise cleaning validation protocols and related documents, as well as create standard procedures for equipment and room cleaning in GMP environments

What you need to apply:

* Bachelor’s degree in a scientific or engineering discipline (e.g., Pharmaceutical Sciences, Engineering, Life Sciences).

* Technical writing certification or similar qualification is an advantage.

* Minimum of 3 years of experience as a technical writer, preferably in the pharmaceutical or engineering sector.

* Experience creating documentation for equipment validation, SOPs, and GMP compliance.

* Familiarity with manufacturing processes in pharmaceutical production, particularly OSD and packaging equipment, including serialization.

* Strong technical writing, editing, and proofreading skills with a focus on clarity, accuracy, and regulatory compliance.

* Knowledge of pharmaceutical and GMP standards and regulations (FDA, EMA, ICH).

* Proficiency in using document management systems (e.g., D2, Veeva, or similar) to store and organize documents.

* Familiarity with pharmaceutical equipment, including OSD manufacturing and packaging machinery (blister, bottle, sachet lines).

* Strong understanding of GMP equipment and cleaning procedures