An exciting new opportunity for a Principal Technical Specialist to join a Leading Biologics company in Ireland. The Technical Support Specialist will report to the Technical Lead and will be a driving force in the Drug Product Vaccines manufacturing team, contributing to vital areas such as formulation, filling, lyophilization, capping, and automated visual inspection.
Overview of your responsibilities (full job description available on request):
Providing technical support across Drug Product manufacturing, including qualification, Commissioning & Qualification, IOQ.
Collaborating closely with cross-functional teams to ensure successful product launches and commercial manufacturing.
Leading and participating in manufacturing investigations to implement effective CAPAs and root cause analysis.
Contributing to continuous process improvement through Lean Six Sigma methodologies.
Creating and revising technical documentation for manufacturing processes.
Serving as a technical representative in audits and inspections.
Acting as a delegate for Manufacturing Technical Lead.
Knowledge, Skills and Experience Required for the Role:
A Bachelor's degree in Engineering or a related discipline.
A minimum of 8 years' experience in cGMP biological or vaccine facilities, with a strong background in sterile manufacturing.
Proficiency in executing on-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches.
Experience in data-driven root cause analysis and continuous improvement initiatives.
Strong problem-solving skills and the ability to lead complex technical investigations.
Familiarity with risk-based manufacturing approaches, including tools like FMEA.
Ideal experience with Lyophilized products, USP1790, Annex1 and Vaccine manufacturing operations. But this is not a prerequisite.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062