The Scientific Technical Specialist provides in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. This role is responsible for all aspects of method and equipment validation, assisting in the effective and efficient running of the method and equipment validation programs. In addition, providing on-going technical support to the site in the area of contamination control. This position will provide technical support to the Vaccines IPT to support the technology transfer and scale-up of new processes for Vaccines IPT manufacture meeting the company’s Manufacturing Division Priorities of: Compliance, Supply, HPO, Strategy and Profit Plan. These are Shift Positions (4 Cycle.) The Technical Specialist will be required to collaborate and facilitate running of activities (e.g. scale-up, PPQ batch manufacture, and license 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.
• 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 Vaccine Technology Transfer group in the Technical Operations Dept.
• Responsible for the technical transfer and scale–up of a new process into Vaccines IPT.
• Input into Technical planning and decisions for the Vaccines IPT, to ensure supply of high quality product through tactical planning and execution of production schedules.
• Technical Review, ownership of and approval of Global Change management records as required.
• Recommend technical approaches in line with global and local standards.
• 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 company’s Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
• Participate and comply with the company’s Quality Management System (QMS) requirements, including ownership, as relevant.
• Responsible for supporting a culture of Continuous Improvement by championing company Six Sigma tools within Technology Transfer for Vaccines IPT.
• Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology.)
• >2 years’ experience in biopharmaceutical/vaccines environment.
• Trackwise/ SAP experience would be an advantage.
• Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project and advantage.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
• Preference for Lean Six Sigma qualification or experience of application of Lean principles.
• Project management qualification such as, Project Management Professional is desirable.
• Evidence of Continuous Professional Development.
• Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.)
• Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
• Demonstrated ability to realize improvement initiatives.
• Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
• Demonstrated high level of problem solving and facilitation skills.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
• Experience in a FDA / HPRA Regulated production environment.
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