CSV Microbiology Analytical Sciences Specialist

Job Description

An amazing opportunity has arisen for a Specialist Computer System Validation Microbiology Analytical Sciences team at Dunboyne. Within in the Our 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.

If leading-edge science and enhancing lives speak to your passions, this exciting opportunity could be your next career move.

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 will act as a Subject Matter Expert (SME) for Computer System Validation (CSV) in the microbiological and virological area. The individual will work in this closely with the microbial and/or virological SME’s from global teams as well as Dunboyne based SME’s.
• Their responsibilities encompass supporting the design, deployment and maintenance of global equipment validation packages in 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.
• On an as-needed basis, the Specialist CSV provides practical and technical support in the validation of equipment used in the microbiological and virological area for alternative microbial methods or the lifecycle. This means that the SME offers both technical and scientific expertise during these processes and travels as required.
• In addition to their responsibilities, the Specialist CSV can also support digitalization projects within the network for microbiological / virological labs or lead digitalization projects locally for the Dunboyne microbiological lab.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Minimum of Level 8 Bachelors Degree, Masters is desirable or equivalent through experience.
• Minimum of 4 - 5 years relevant experience in preferably 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.
• Knowledge of regulatory and quality guidelines (GMP) in relation to equipment.
• Strong focus on quality, safety and compliance.
• Demonstrated initiative, and innovative process-oriented thinking within a team environment.

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Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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