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Technical Writer - Biotech Manufacturing Support, Dublin
Client:
JobContax
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
6bb3a78299b4
Job Views:
2
Posted:
27.04.2025
Expiry Date:
11.06.2025
Job Description:
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 Laoghaire, 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 gain experience at Ireland's leading aseptic manufacturing plant.
You will be responsible for managing change controls critical to site development and updating operational documentation 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 generating training materials and potentially provide training on scientific or technical aspects of the process.
Liaise with Manufacturing, Inspection, and Engineering regarding documentation changes in an effective and timely manner.
Develop protocols for manufacturing and inspection to support change controls, non-conformances, and troubleshooting investigations with support from relevant SMEs.
Participate in projects as part of continuous process improvement and troubleshooting.
Own and manage change controls as required.
Issue and update paper batch records according to production schedules.
Coordinate with Quality Assurance to ensure GMP standards are maintained in line with current operational standards.
Partner with Operations lead and SMEs to ensure updates are correct and aligned with project timelines.
Perform document trending after project completion to identify key issues or mistakes in document processing.
Support data verification of operational protocols, reports, and risk assessments.
Assist in reducing document turnaround times.
Use specified software packages and procedures to compile and maintain documentation, including SOPs.
Provide technical and clerical support to manufacturing, inspection, and engineering teams in documentation, data collation, and SOP tracking.
Ensure non-conformances are triaged within the established goals and serve as a deviation owner for minor deviations.
Own corrective and preventative actions and verify their effectiveness.
Support execution of commissioning, qualification, and validation protocols as required, which may require flexible working hours.
Requirements
* Bachelor’s degree in Science or Engineering.
* 3+ years of experience in Chemistry, Microbiology, Engineering, or Validation within biotech, pharma, or healthcare organizations.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is advantageous.
* Strong project management and organizational skills, including ability to follow through on assignments.
* Excellent verbal and written communication skills, with strong technical writing skills for GMP documentation and good presentation skills.
* Ability to escalate issues professionally and timely.
* Ensures compliance within regulatory environments.
* Ability to work independently and deliver quality results with minimal supervision.
* Experience leading cross-functional teams.
* Ability to manage multiple priorities in a fast-paced environment.
Package
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