CSV Microbiology Analytical Sciences Specialist
An amazing opportunity has arisen for a Specialist Computer System Validation Microbiology Analytical Sciences team at Dunboyne. Within the Manufacturing Division, the Micro Analytical Sciences (MAS) section within the Global Quality Large Molecule Analytical Sciences (GQLMAS) organization, located in Dunboyne scientifically supports the microbiological laboratories in the commercial production sites for vaccines, biologics, and small molecules.
The MAS team plays a crucial role in supporting the transfer, troubleshooting, and life cycle management of the microbiological test methods (including equipment) for all modalities. This includes compendial test methods, non-compendial test methods, and alternative microbiological methods. Furthermore, MAS is seen as the owner for global microbiological methods and equipment packages to structure the transfer of the microbiological test methods.
As a Computer System Validation Microbiology Specialist, your energy, knowledge, innovation, and leadership will be invaluable in carrying out the following responsibilities:
* Supporting the global equipment packages and ensuring these are up to date with current guidelines and acting as a Subject Matter Expert (SME) for Computer System Validation (CSV) in the microbiological and virological area. The individual will work closely with the microbial and/or virological SMEs from global teams as well as Dunboyne based SMEs.
* Supporting the design, deployment, and maintenance of global equipment validation packages in accordance with guidelines, as well as supporting life cycle projects related to equipment used in the microbiological/virological labs and leading it for the Dunboyne Micro Analytical Sciences (MAS) team.
* Providing practical and technical support in the validation of equipment used in the microbiological and virological area for alternative microbial methods or the lifecycle as needed. This means offering both technical and scientific expertise during these processes and traveling as required.
* Supporting or leading digitalization projects within the network for microbiological/virological labs locally for the Dunboyne microbiological lab.
What skills you will need:
* Minimum of Level 8 Bachelor's Degree; a Master's is desirable or equivalent through experience.
* Minimum of 4 - 5 years relevant experience in the Pharmaceutical Industry.
* Strong project management skills & proven ability to manage complex projects.
* Knowledge of regulatory and quality guidelines (GMP).
* Proficient networker in global multidisciplinary teams.
* Affinity with microbiology/virology.
* Strong focus on quality, safety, and compliance.
* Demonstrated initiative and innovative process-oriented thinking within a team environment.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing
Industries
Pharmaceutical Manufacturing
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