Mylan Teoranta
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing The Microbiology Laboratory Technician II will be responsible for day to day microbiological testing (raw materials, waters in-process & finished products) and environmental monitoring (classified areas & compressed gases), including completing the relevant GMP documentation and recording results. This position also includes report writing, investigation work and review of laboratory raw data.
Every day, we rise to the challenge to make a difference and here’s how the Microbiology Laboratory Technician II role will make an impact:
- Testing of raw materials, in-process & finished products, waters and validation samples for bioburden using membrane filtration or direct method.
- Testing of raw materials, in-process & finished products, waters, validation samples and components for endotoxin using Gel Clot or Kinetic assays.
- Testing of finished products samples and components for sterility.
- Environmental monitoring of classified areas and compressed gases.
- Identification of microorganisms to species level.
- Growth promotion and sterility testing of microbiological media..
- Support the process qualification and stability programs.
- Perform test method validations (bioburden, endotoxin & bacteriostasis/fungistasis) and assist in completing the associated reports.
- Observing and analysing results from environmental and personnel monitoring plates from classified areas
- Observing and analysing results from microbiological tests (Bioburden/Sterility)
- Trending of microbiological test results and results from environmental/ personnel monitoring of classified areas
- Inspect media fills.
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- Monitoring stock levels of media plates and test consumables and ordering when required
- Provide training to other team members as required. Ensure all training delivered is documented appropriately.
- Perform Container Closure Integrity testing.
- Assist and maintain the Microbiology laboratory calibration schedule.
- Complete Laboratory investigation reports as assigned.
- Complete Grade C and Grade D environmental monitoring trend reports and WFI summary Reports as assigned.
- Complete review of raw data and lab logbooks as assigned
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
- Minimum of a Bachelor's degree (or equivalent) in a Science related discipline (preferably Microbiology) and 2-4 years’ experience within a Microbiology department of a pharmaceutical company.
- Ability to perform Sterility, Bioburden and Endotoxin testing.
- Must possess knowledge of the USP and Ph. Eur. microbiological requirements.
- Ability to prepare and execute comprehensive investigation reports using Risk Analysis Tools.
- Must possess knowledge and have experience of working within an FDA/HPRA regulated facility.
- Familiar with the environmental monitoring requirements of a sterile manufacturing facility.
- Third level mathematics ability required.
- Excellent attention to detail.
- Computer skills including Word, Excel
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.