Position:
Technical Support Specialist
Location:
Dundalk, Ireland
Role Overview:
We are seeking a Technical Support Specialist to provide expert support across Drug Substance manufacturing activities, including cell culture, bioreactor operations, and downstream processing. The role involves equipment qualification, technical guidance, continuous improvement initiatives, and cross-functional collaboration to support successful product launches and commercial manufacturing.
Key Responsibilities:
* Provide technical support to the DS manufacturing team for cell expansion, bioreactor, and downstream processes.
* Lead and execute equipment commissioning, qualification, and validation activities (IQ/OQ).
* Coordinate technical deliverables to ensure timely and compliant product manufacturing.
* Support the operations team during commercial manufacturing activities.
* Lead or participate in manufacturing investigations, ensuring root cause analysis and implementation of CAPAs.
* Support batch disposition by providing SME technical guidance.
* Identify and implement continuous improvement projects to enhance manufacturing capabilities.
* Use Lean Six Sigma tools to drive process and quality improvements.
* Create and revise technical documentation including SOPs, batch records, and technical memos.
* Provide technical leadership to the DS organization in partnership with senior scientists.
Requirements:
* Minimum 5 years' experience in biological, vaccine, or pharmaceutical manufacturing in a cGMP environment; sterile manufacturing experience preferred.
* Ability to work in a matrix team environment and participate in FAT, SAT, IQ/OQ, and engineering batch activities.
* Strong data-driven problem-solving skills with experience in root cause analysis and prioritizing continuous improvement initiatives.
* Knowledge of risk-based manufacturing approaches (e.g., FMEA).
* Flexibility to adapt to changing project priorities.
Education:
* Bachelor's degree in Engineering, Science, or related technical discipline.
Preferred Skills & Experience:
* Previous operations experience in vaccine or biologics manufacturing.
* Familiarity with USP1790, Annex 1, and other regulatory requirements.
* Knowledge of DS processes including cell culture and downstream operations.
* Experience in start-up facilities is an advantage.
* Strong planning, organizational, and technical writing skills.
* Excellent oral and written communication skills.