Our client is Cork is hiring a Microbiology Senior Technical Specialist. This position requires someone with strong Microbiology experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories.
Leading the effective and efficient running of Microbiology Projects both globally and locally, Analytical Method Transfers, Validations, Verifications, Investigations and Change Control.
The successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytic Sciences group. The successful candidate will be required to demonstrate a high level of technical leadership, collaboration, and coaching to facilitate the team in becoming a high performance organisation and ensuring timely delivery of projects.
Central to this objective will be the active engagement and communication with all internal and external stakeholders. A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for analytical method stabilisation and process optimisation studies which will deliver and maintain process robustness.
- Good knowledge of working practices required for working in a Microbiology laboratory (e.g. Bioburden, Endotoxin, Sterility testing etc.)
- Support assay optimisation/investigations within the Microbiology area
- Technology Transfer
- Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
- Lead the delivery of projects whilst adhering to project timelines through the use of project management tools Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other our company Sites and contract laboratories as required.
- Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing monitoring.
- Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
- Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc.
- Collaborate with internal partners (i.e. other sites, R&D) and externally with CROs
Qualifications, Skills & Experience Required
- BSc in a relevant Science discipline
- Experience with leading analytical method validations/Verifications
- Self-motivated and ability to work as part of a team with good project management Skills
- High level written and verbal communications with advanced PC skills
- Knowledge and experience of operating in a development and commercial lab environment.
- Ph.D./M.Sc. qualification (Science)
- Knowledge of and experience in applying Six Sigma and Lean methodologies,
- Equipment commissioning and qualification.
For further information on this Senior Microbiologist role in Cork please contact Clara Burke on 086 8168273 / email@example.com
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