Job Description:
We are seeking a skilled Technical Specialist to support the development and implementation of our vaccine process. The successful candidate will have strong technical expertise and excellent communication skills.
Key Responsibilities:
* Provide technical support to ensure seamless execution of processes and procedures.
* Leverage cross-functional project teams to drive continuous improvement and innovation in the vaccine process.
* Lead investigations, coaching, and reviews to maintain high-quality standards and compliance with regulatory requirements.
* Represent the team on cross-functional projects, fostering collaboration and effective communication among stakeholders.
* Promote Quality, Compliance, and Safety by participating in and complying with our Quality Management System (QMS) requirements.
Requirements:
* Degree or Master's in Science or Engineering discipline, preferably Biotechnology.
* At least 4 years' experience in biopharmaceutical/vaccines environment.
* Strong knowledge of material management and associated systems.
* Direct experience with Single Use Technology, including operational use, problem-solving, and vendor engagement.
* Exceptional technical and process knowledge with background and experience in drug substance processing unit operations, including UF/DF, Lyophilisation, Bottle filling, PAT, and Single-use technology deployment.
* Excellent collaboration and project management skills; ability to establish good working relationships, resolve conflicts, provide feedback, and devise creative solutions to problems.
* Knowledge of FDA / HPRA Regulations and applicable standards for Quality and Regulatory requirements within the biopharmaceutical/vaccine area.
What We Offer:
A competitive hourly rate and the opportunity to work with a dynamic team.