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Technical Writer

4 weeks ago

Dublin, Dublin City, Ireland TN Ireland Full time

Technical Writer - Biotech Manufacturing Support

Employment Type: Contract

Experience: 3+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

Job Responsibilities:
  1. Own and manage change controls critical to site development.
  2. Manage operational documentation updates as required by each project.
  3. Develop, update, and maintain Operations procedures in accordance with site and corporate requirements.
  4. Serve as a document owner.
  5. Assist in generating training materials and may assist in providing training on scientific or technical aspects of the process.
  6. Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner.
  7. Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs.
  8. Involvement in projects as part of continuous process improvement and/or troubleshooting.
  9. Ownership and management of change controls as required.
  10. Issuance and updates of paper batch records in line with production schedule.
  11. Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS.
  12. Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/timelines.
  13. Perform document trending upon project completion to identify key issues/mistakes in document processing.
  14. Support data verification of Operations owned protocols reports and risk assessments.
  15. Support the production support team in reducing document turnaround times.
  16. Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs.
  17. Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs.
  18. Ensure Non-conformance are triaged within the established goal and serve as a deviation owner for minor deviations.
  19. Own corrective/preventative actions and effectiveness verification.
  20. Support execution of C&Q, characterisation, functional testing protocols as required by project. NOTE: This may require flexible working hours.
Requirements:
  1. Bachelor's degree in a Science or Engineering discipline.
  2. 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization.
  3. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is an advantage.
  4. Strong Project Management and organizational skills, including ability to follow assignments through to completion.
  5. Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.
  6. Escalate issues professionally and in a timely manner.
  7. Ensure compliance within regulatory environment.
  8. Demonstrated ability to work independently and deliver right first-time results under minimal direction.
  9. Experience participating in and leading cross-functional teams.
  10. Experience in managing multiple, competing priorities in a fast-paced environment.
Package:#J-18808-Ljbffr