Technical Writer

Summary:
A biopharmaceutical company in South Dublin requires a Technical Writer. The incumbent will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.

Responsibilities:

• Develop/ Update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner.
• Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs.
• Involvement in projects as part of continuous process improvement and / or troubleshooting.
• Ownership and management of change controls as required.
• Issuance and updates of paper batch records in line with production schedule.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS.
• Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
• Perform document trending upon project completion to identify keys issues/mistakes in document processing.
• Support data verification of Operations owned protocols reports and risk assessments.
• Support the production support team in reducing document turnaround times.
• Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs.
• Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs.
• Ensure Non-conformance are triage within the established goal and serve as a deviation owner for minor deviations.
• Own corrective /preventative actions and effectiveness verification.
• Support execution of C&Q, characterisation, functional testing protocols as required by project.

Qualifications & Experience:

• Bachelor’s degree in a Science or Engineering discipline.
• 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage.
• Strong Project Management and organizational skills, including ability to follow assignments through to completion.
• Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.