Description:
PE Global is currently recruiting for a Tech Writer on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.
Job Summary:
An exciting opportunity has opened in the ADl Manufacturing Support team for a Technical Writer. In this role, you 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:
1. 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.
2. Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner
3. Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs
4. Involvement in projects as part of continuous process improvement and / or troubleshooting
5. Ownership and management of change controls as required
6. Issuance and updates of paper batch records in line with production schedule
7. Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS
8. Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
9. Perform document trending upon project completion to identify keys issues/mistakes in document processing.
10. Support data verification of Operations owned protocols reports and risk assessments.
11. Support the production support team in reducing document turnaround times
12. Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs
13. Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs
14. Ensure Non-conformance are triage within the established goal and serve as a deviation owner for minor deviations.
15. Own corrective /preventative actions and effectiveness verification.
16. Support execution of C&Q, characterisation, functional testing protocols as required by project.
Education and Experience:
17. Bachelor’s degree in a Science or Engineering discipline.
18. 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization
19. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage
20. Strong Project Management and organizational skills, including ability to follow assignments through to completion
21. Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (, investigations, procedures, change controls) and good Presentation skills
22. Escalate issues professionally and in a timely manner
23. Ensures compliance within regulatory environment
24. Demonstrated ability to work independently and deliver right first-time results under minimal direction
25. Experience participating in and leading cross-functional teams
26. Experience in managing multiple, competing priorities in a fast-paced environment
Interested candidates should submit an