Technical Writer - Biotech Manufacturing Support
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site Based
Pay: €30 - €38 per hour
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.
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.
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. NOTE: This may require flexible working hours.
Requirements
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
Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
Escalate issues professionally and in a timely manner
Ensures compliance within 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
Package
Contract role - Hourly rate €30 - €38 per hour
Minimum 12 month contract