This is an 11 month contract with a view to extension
The Associate Technical Specialist will be required to collaborate and facilitate running of activities (e.g. support batch manufacture and licence submissions) in the Vaccines IPT value stream for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to Vaccines IPT.
This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.
• Ensure the highest Quality, Compliance and Safety standards primarily with Technology Transfer but relating to all activities.
• Work within a team to enable the team’s performance within the Technology Transfer team
• Support the technical transfer and provide technical support to manufacturing operations.
• Preparation and review of Qualification protocols (IQ, OQ and PQ)
• Analyses the results of testing and determines the acceptability of results against predetermined criteria.
• Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
• Contribute for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Participate and comply with the Quality Management System (QMS) requirements.
• Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
• 1-2 years’ experience in biopharmaceutical/vaccines environment
• Trackwise/ SAP experience would be an advantage
• Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
• Experience in an FDA / HPRA Regulated production environment desirable.
• Strong problem-solving, collaboration, and written and oral communication skills.
• Strong organizational, interpersonal, writing, and time management skills.
• Proven ability to work independently Self-motivated and collaborate effectively as part of a team.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory
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