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Siemens Healthineers has an opening for a Senior QC Microbiology Technician/Microbiology Specialist at our In-Vitro Diagnostic (IVD) instrumentation / reagent manufacturing site in Llanberis, Gwynedd, North Wales. The QC Microbiology team are responsible for bioburden testing of raw materials, in-process samples and product release samples as well as environmental microbiological monitoring.

The successful applicant will report to the Instrumentation QC Service, Microbiology & LIMS Manager and is a member of the wider Quality Management team, collectively responsible for maintaining and improving quality & compliance in the manufacture and support of our products and services. 

Your Role:

• You will have responsibility for microbiology test methods and performs microbiological testing of raw materials, products, equipment and production environments in-line with all associated procedural and Health and Safety requirements. 
• Microbiology SME who participates in investigation and validation activities and internal and external audits. Complete quality activities (QN/CAPA/procedures) related to the microbiology department. 
• Participate in or lead root cause investigation of out of specification contamination events.
• Proactively identify process improvements and support implementation.
• Prioritise daily tasks such as testing, cleaning and data entry and complete within the timescale allocated.
• SME responsible for microbiology test methods and design of additional experiments for any validation requirements.
• Meeting the regulatory and standard requirements and acting as the site SME for internal and external audits.
• Leads investigation and resolution of CAPAs and/or non-conformances for any quality issues related to microbiology.
• Responsibility for monitoring and control of unwanted microbial growth throughout the facility.

Your Expertise:

• Familiarity with aseptic technique in a GLP/GMP environment.
• Familiarity with microbiology techniques such as plating and reading off cfu results from the plates, environmental sampling (water, air, particle etc).
• Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline (Microbiology or other suitable science subject) OR appropriate and commensurate experience.
• Familiarity with GLP, GMP and GDP.
• Knowledge of bacteria, yeasts and moulds and specifically their characteristics, appearance and identification.
• A sound knowledge of data analysis and IT literacy, including Word, Excel and Access.
• Experience of root cause investigation of contamination events and control of contamination in a non-sterile manufacturing environment.
• Experience of quality activities such as QNs and CAPAs is beneficial but not essential as training can be provided.

Our Benefits:

• 26 days' holiday with the option to buy or sell an additional 5
• Up to 10% employer pension contribution
• Share and bonus scheme
• Access to our flexible benefits from private medical insurance to dental cover
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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