Principal Technical Support Specialist
Location: Dundalk, County Louth, Ireland
Responsibilities
* Provide Technical Leadership within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.
* Execution of equipment qualification deliverables during the project phase including equipment Commissioning & Qualification, IOQ.
* Coordinate technical deliverables within Drug Product to support successful product launch.
* Provide technical support to the operations team during commercial manufacturing.
* Lead or participate in manufacturing investigations with cross‑functional teams to ensure 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 compliance and manufacturing capabilities within the Drug Product.
* Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
* Create and revise technical documents including manufacturing batch records, SOPs, and technical memos.
* Partner with the site MS&T scientist to provide comprehensive technical leadership to the DP organization.
* Participate in regulatory, client and internal audit inspections as the technical representative.
* Act as delegate for Manufacturing Technical Lead.
Requirements
* Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
* Minimum 5 years working in a biological, vaccine or pharma facility; preferred candidate will have cGMP experience in a sterile manufacturing environment.
* Ability to operate within a matrix team to execute floor activities such as FAT, SAT, IQ/OQ, and engineering batches.
* Experience in a data‑driven approach to root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma).
* Experience in leading and resolving complex technical investigations.
* Experience in a risk‑based approach to manufacturing using tools such as FMEA.
* Ability to adapt to changing priorities as project demands change.
* Previous experience in an operations role within vaccine manufacturing preferred.
* Knowledge of USP1790 and regulatory requirements such as Annex 1 desirable.
* Ability to explain complex technical issues to external customers and agencies.
* Experience with lyophilized products advantageous.
* Experience in start‑up facility advantageous.
* Demonstrated excellence in planning and organizational skills.
* Demonstrated skills in communication (oral and written) and in particular technical writing.
Desired Skills and Experience
* Bachelor's degree in Engineering or a Science‑related field.
* Minimum of 5 years’ experience in a biological, vaccine, or pharma facility with a strong preference for sterile manufacturing background.
* Proven experience in equipment qualification (C&Q, IOQ), technical investigations, root cause analysis, and CAPA.
* Skilled in applying Lean Six Sigma and risk‑based tools (e.g., FMEA).
* Excellent technical writing and communication skills are essential.
Seniority Level
* Mid‑Senior level
Employment Type
* Contract
Job Function
* Science
Industries
* Pharmaceutical Manufacturing
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