We're currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Key Responsibilities:
* Provide Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream.
* Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
* Coordinate technical deliverables within Drug Substance to support the successful product launch.
* Provide technical support to the operations team's during commercial manufacturing.
* Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
* Support Batch Disposition activities by providing SME technical support for comment resolution.
* Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance.
* Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
* Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
* In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization.
Education & Experience Requirements:
* Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.
* Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
* Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
* Experience in a risk-based approach to manufacturing through use of tools such as FMEA
If interested in this posting please feel free to contact Seán McCarthy on or for further information.