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