Microbiologist II
Elkton, MD, US
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Microbiologist II independently works on projects as assigned in establishing and maintaining microbiology programs which include contamination control environmental monitoring, bioburden testing, bacterial endotoxins testing, and critical utilities testing (water and compressed air). S/he collaborates with cross functional groups to investigate laboratory and microbiological issues and implements corrections and improvements that directly affect product safety, quality, and operational efficiency.
Job Details/Responsibilities
- Supports microbiology/sterility assurance programs including contamination control, environmental monitoring, and product microbiological monitoring. Generates trend analysis reporting for microbiology programs. Supports cleanroom certification and qualification activities as assigned.
- Conducts laboratory and excursion investigations and supports nonconformances and CAPAs related to the areas of microbiology/sterility assurance.
- Authors, reviews and/or approves document revisions. Supports change requests/change orders for microbiology/sterility assurance change control initiatives.
- Independently develops, executes, and implements microbiological test methods in accordance with applicable regulations (FDA, ISO, AAMI, etc.).
- Maintains current knowledge of microbiological testing techniques and equipment. Supports and executes qualification activities (IQ, OQ, PQ) and maintains laboratory equipment to support project initiatives. Performs maintenance and calibrations on laboratory equipment.
- Performs detailed technical review and approval of laboratory test records, protocols/reports, etc.
- Performs microbiological testing, including environmental monitoring, bioburden and bacterial endotoxin.
- Trains other technicians and manufacturing operators in microbiological test methods and use of laboratory equipment.
- Supports internal and external audits by preparing documentation, responding to observations, and participating in audit readiness activities.
Knowledge, Skills and Abilities (KSA)
- Working knowledge of microbiological test methods, practices (e.g., contamination control, environmental monitoring, bioburden, bacterial endotoxin, water testing, microbial characterization, etc.), and standards (e.g. ISO 14644 series, ISO 17141, ISO 11737 series, ANSI ST72, etc.)
- Effective communication (written and verbal)
- Demonstrated ability to assess issues, develop and execute solutions with urgency
- Scientific and analytical mindset; critical thinking
- Attention to detail and documentation accuracy
- Cross-functional collaboration
- Regulatory and compliance mindset
Qualifications/ Background Experiences
- Bachelor’s degree in Microbiology or related discipline, such as Biology, Biological Sciences, Biomedical Engineering, etc.
- Minimum of 5 years relevant microbiological experience in the medical device/pharmaceutical industry, including cleanroom and environmental monitoring testing, and bacterial endotoxin/bioburden testing. Experience in medical device industry preferred.
- Strong technical writing skills with demonstrated experience in authoring scientific protocols and reports.
- Experience supporting audits and working within a regulated environment (FDA, ISO, etc.).
- Ability to perform laboratory and OOS investigations as related to microbiological testing.
Preferred:
- Experience with training/mentoring technicians and junior level microbiologists in microbiological test methods.
- Demonstrated experience in qualification of testing equipment and the development and qualification of test methods from scientific methodologies.
- Proficiency in data analysis tools (e.g., Excel, Minitab) and statistical interpretation.
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.