Principal Technical Specialist - Validation/Technical Vaccines
Our client, a pharmaceutical company in Cork are currently looking to recruit a Principal Technical Specialist - Validation/Technical Vaccines for their site.
- 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.
- 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.
- 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.
- 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.
- > 5 years' experience in a similiar role in a manufacturing environment. Ideally in a senior role.
- Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing, technology, validation, engineering, quality, analytical)
- Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations, with experience of successfully delivering a significant process / technical project
- Demonstrated process, qualification and technology SME background within the pharmaceutical or Biopharmaceutical industry.
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
- Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment.
- Demonstrated leadership, including change management skills with a continuous improvement focus
- Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
- Demonstrated ability to realize improvement initiatives.
- Demonstrated high level of problem solving and facilitation skills.
- Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
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