Tech Writer

The Role

PE Global are recruiting for a Technical Writer for our biopharmaceutical client based in Dun Laoghaire, Dublin. This is a 12 month contract role. Hybrid working options.

Job Responsibilities

• Develop, update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in the 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 key 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 conformances are triaged within the established goal and serve as a deviation owner for minor deviations.
• Own corrective/preventive actions and effectiveness verification.
• Support execution of C&Q, characterisation, functional testing protocols as required by project.

Education and Experience

• Bachelor's degree in a Science or Engineering discipline.
• 3+ years of experience in Chemistry, Microbiology, Engineering or Validation gained within a biotech, pharma or healthcare organisation.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is an advantage.
• Strong project management and organisational skills, including the ability to follow assignments through to completion.
• Excellent verbal and written communication skills: strong technical writing skills for GMP documentation, such as investigations, procedures and change controls, and good presentation skills.
• Escalate issues professionally and in a timely manner.
• Ensure compliance within a regulatory environment.
• Demonstrated ability to work independently and deliver right first time results under minimal direction.
• Experience participating in and leading cross functional teams.
• Experience in managing multiple competing priorities in a fast paced environment.

Interested candidates should submit an updated CV.