Vaccine Process Technical Specialist - Ireland
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- This position will provide expert technical & equipment support to the Vaccine IPT Processing area.
- This role will ensure on-going optimization of the process and manufacturing support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.
- The Technical Support role will be required to collaborate, coach and facilitate the IPT team to ensure the effective and efficient on-time delivery of batch production within the IPT area. This requires the delivery of process excellence and reliability across all areas of the IPT.
- Lead and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g.CAPA/DN/MDNs etc).
- Lead and close process related deviations and reports.
- Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training.
- Protocol/report authoring/execution/oversight/approval as appropriate
- Ensure highest Quality, Compliance and Safety standards.
- Participate and comply with the company Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant.
- Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
- Provide technical, process and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and process’s.
- 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.
- Author/approve Change controls and MIDAS documents as appropriate.
- 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
- Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology)
- 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.
- > 3 years Engineering/Technical experience in biopharmaceutical/vaccines environment
- Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
- Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing, technology, validation, engineering, quality, analytical).
- Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.
- Experience in a FDA / HPRA Regulated production environment.
- Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Demonstrated high level of problem solving and facilitation skills.
- Demonstrated leadership, including change management skills with a continuous improvement focus
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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