Latest Microbiology Job Openings at Varian in Austin, TX – Apply Below
Role: Microbiologist II
Location: Austin, TX
Latest Microbiology Job Openings At Varian, a Siemens Healthineers Company, we bring together the world’s best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
If you want to be part of this important mission, we want to hear from you.
About the Role:
- We are seeking a highly skilled and motivated Microbiologist II with 2-3 years of experience in a medical device company to join our dynamic team.
- The ideal candidate should possess a familiarity with different sterilization modalities and a strong background in Microbiology testing within a GMP environment.
- As a Microbiologist II, you will play a crucial role in ensuring the safety and quality of our medical devices through rigorous testing and analysis.
Responsibilities:
- Lead microbiological testing on medical devices- raw materials and finished products following established procedures and work instructions.
- Create the standard operating procedures (SOPs) and testing protocols for the laboratory including tests like Bioburden, Endotoxin, and Viable testing.
- Perform environmental monitoring of the manufacturing facilities including air, water, and surface sampling, to maintain a controlled and clean environment. Perform assessments of potential risks (microorganisms or others) and ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to provide microbiological expertise during new product development, routine manufacturing, and during validation or revalidation processes.
- Maintain and calibrate microbiology laboratory equipment and ensure proper functioning to achieve accurate and reliable test results.
- Conduct routine sterilization monitoring including but not limited to quarterly Dose Audits and results from Biological Indicators.
- Assist in the validation and qualification of sterilization processes such as ethylene oxide (EO), gamma irradiation, and steam sterilization.
- Investigate and analyze deviations, out-of-specification results, and non-conformances related to microbiological testing, proposing corrective and preventive actions (CAPAs) as needed.
- Document and report test results, keep accurate and organized records, and coordinate the preparation of technical reports including periodic trending for internal and external stakeholders.
- Stay current with industry trends, best practices, and regulatory guidelines related to microbiology, sterilization, and GMP compliance.
- Lead internal and external audits as a Microbiology lead.
- Participate in continuous improvement initiatives to enhance laboratory processes, efficiency, and overall quality.
- Plan and develop the implementation of new microbiological testing methods or technologies for cost-saving initiatives.
- Ensure adherence to safety guidelines and maintain a clean and orderly work environment.
Minimum Required Skills and Knowledge:
- Bachelor’s degree in Microbiology, Biology, or a related field.
- Master’s degree in Microbiology, Biology, or a related field- Preferred.
2-3 years of hands-on experience with microbiology testing in a medical device company or a similar GMP-regulated environment. - Knowledge of relevant regulatory standards, such as ISO 13485, FDA requirements, FDA guidance, and EU MDR requirements.
- Familiarity with ISO 10993, ISO 11137, ISO 11135, and ISO 11765.
- Familiarity with USP <161>, USP <85>, and other related reference standards.
- Leadership qualities.
- In-depth understanding of microbiological testing techniques like bioburden, endotoxin, sterility, and microbial identification methods.
- Familiarity with sterilization processes commonly used in the medical device industry.
- Proficiency in using laboratory equipment and software for data analysis and reporting.
- Strong attention to detail and the ability to work meticulously in a controlled laboratory setting and office environment.
- Excellent problem-solving skills and the capacity to work effectively in a team environment.
- Effective communication and documentation skills to present findings and collaborate with cross-functional teams.
- Adherence to safety protocols and a commitment to maintaining a compliant and quality-driven work environment.
- Proficient in utilizing business tools such as E-mail, Microsoft Word, Excel, Visio, and PowerPoint.
- Experience with SAP or equivalent ERP and productivity software desired.
- This is an onsite role with a 10% travel requirement.
