Stryker Senior Microbiologist Job Opportunity For MSc, BTech & MTech Candidates

Stryker Senior Microbiologist Job Opportunity For MSc, BTech & MTech Candidates

Stryker Senior Microbiologist Job Opportunity For MSc, BTech & MTech Candidates. Stryker Microbiology and Biotechnology Senior Microbiologist Job. Interested and eligible applicants can check out all of the details on the same below

Possible Interview Questions are posted below

Senior Microbiologist – Lab

Gurugram, Haryana, IN

Are you interested in working for a global company where you can work across functions and on a wide variety of projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now!

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

What you will do:

• Responsible for testing in microbiology lab & simulated reprocessing (cleaning and sterilization -instruments life test) projects.
• Cleaning disinfectant and sterilization validation of medical devices/ instruments/ clean classified areas. Perform qualification and validation of microbiological methods and equipment(s).
• Performs BI (Biological Indicator), Microbial limit test, growth promotion testing, environment monitoring, water testing and other general microbiological tests required for incoming, intermediate and finish sterile products/ medical devices.
• Apply GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to sterilization, cleaning, disinfection, bioburden, bacterial endotoxin, of medical devices/ pharma products.
• Support team members to create or improve procedures, policies, processes, systems, and technology requirements.
• Independently lead and timely execution of complete project deliverables. Hold self-accountable to deliver on tasks & meet business deadlines.
• Audits/ NC CAPA/ Deviations/ change control/ Procedures improvements/ risk evaluations and data/ record/ report reviews. Well versed in Pharma/ medical devices QMS.

What you need:

• M.Sc./ B Tech/ M Tech – in Microbiology, Biotechnology, Bioengineering.
• Experience: 5-8 years, Experience: Min 5 years of experience in testing of device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
• Worked with different regulatory bodies (USFDA, EU, PMDA, MHRA etc) in production requirements of medical devices/pharma etc.
• Strong Instrument Working Knowledge used in microbiology and analytical laboratories.
• Possess an in-depth knowledge of the industry and competitive landscape, ensure effective implementation, and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 17025, ISO 14971 throughout the design and development process various test requirements.
• Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques. Moist heat is preferred.
• Demonstrated organizational and written/verbal communication skills.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com

APPLY ONLINE

Possible Interview Questions:

1. Can you describe your experience in testing medical devices or pharmaceutical products in a microbiology lab? What specific microbiological tests and techniques have you performed? Answer: In my role as a Senior Microbiologist, I have extensive experience in testing medical devices and pharmaceutical products in a microbiology lab. I have conducted a range of microbiological tests such as Biological Indicator (BI) testing, microbial limit testing, growth promotion testing, and environmental monitoring. Additionally, I have expertise in cleaning disinfectant and sterilization validation of medical devices and clean classified areas. I am well-versed in techniques such as gamma irradiation, ethylene oxide, and moist heat sterilization.
2. How do you ensure compliance with regulatory guidelines and standards such as GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP in your work? Can you provide an example of a project where you successfully applied these guidelines? Answer: Compliance with regulatory guidelines and standards is crucial in the microbiology lab. I ensure adherence to GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines throughout the testing processes. For example, in a recent project involving the validation of a cleaning and sterilization process for medical devices, I followed the relevant standards and guidelines closely. This included conducting testing and validation in accordance with ISO 13485 and 21CFR820 requirements. By implementing these guidelines, we achieved compliance and ensured the safety and efficacy of the products.
3. How have you contributed to process improvements, procedures, and policies in your previous roles as a Senior Microbiologist? Can you provide an example of a situation where you identified an area for improvement and implemented changes? Answer: As a Senior Microbiologist, I have actively contributed to process improvements, procedures, and policies within the microbiology lab. For instance, in a previous role, I identified the need to streamline the environmental monitoring process to improve efficiency and accuracy. I proposed a new system that included automated data collection and real-time monitoring. By implementing this change, we reduced the time required for monitoring, enhanced data accuracy, and improved overall laboratory productivity.
4. How do you stay updated with industry trends, regulations, and competitive landscape in the microbiology field? Can you provide examples of how you have applied this knowledge in your work? Answer: Staying updated with industry trends, regulations, and the competitive landscape is essential as a Senior Microbiologist. I actively participate in industry conferences, seminars, and workshops to stay informed about the latest developments. Additionally, I regularly review relevant scientific literature and publications. This knowledge allows me to effectively implement new techniques and methodologies in the lab, ensuring that our testing processes align with current industry best practices and meet regulatory requirements.
5. Can you describe your experience in working with different regulatory bodies such as USFDA, EU, PMDA, and MHRA in relation to the production requirements of medical devices or pharmaceuticals? How have you ensured compliance with these regulatory bodies? Answer: Throughout my career, I have worked closely with various regulatory bodies, including USFDA, EU, PMDA, and MHRA. I have a strong understanding of the production requirements and regulatory expectations for medical devices and pharmaceuticals. To ensure compliance, I actively monitor updates and changes in regulations issued by these bodies. I have successfully prepared and participated in audits by these regulatory authorities, ensuring that our processes, documentation, and testing methods align with their requirements.

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