Microbiologist I

Terumo•Elkton, MD

About The Position

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 SummaryThe Microbiologist I performs routine microbiological testing, including bioburden, endotoxin, growth promotion, and critical utilities testing to support product quality, contamination control, environmental monitoring, and sterility assurance programs. This role executes established test methods, collects and processes samples, and documents results in accordance with applicable procedures and regulatory requirements. The Microbiologist I works under direct supervision and receives guidance for non‑routine work. S/he collaborates with cross functional groups to investigate laboratory and microbiological issues.

Requirements

Basic knowledge of microbiological test methods, practices (e.g. environmental monitoring, bioburden, bacterial endotoxin, water testing, etc.), and standards (e.g. ISO 14644 series, ISO 17141, ISO 11737 series, ANSI ST72, etc.)
Effective communication (written and verbal)
Understanding of Good Documentation Practice (GDP) and Good Laboratory Practice (GLP)
Ability to follow established procedures and accurately record data. Attention to detail and commitment to quality.
Attention to detail and documentation accuracy
Cross-functional collaboration
Strong technical writing skills with demonstrated experience in authoring scientific protocols and reports.
Basic proficiency with Microsoft Office applications (Word, Excel, Outlook).
Assist with laboratory and OOS investigations as related to microbiological testing.
Bachelor’s degree in Microbiology or related discipline, such as Biology, Biological Sciences, Biomedical Engineering, etc.
Minimum of 1-3 years relevant microbiological experience in the medical device/pharmaceutical industry, including cleanroom and environmental monitoring testing, and bacterial endotoxin/bioburden testing.

Nice To Haves

Experience in medical device industry
Microbial characterization experience, such as Gram stain

Responsibilities

Performs routine microbiological testing, including environmental monitoring, bioburden, microbial characterization by Gram stain, and bacterial endotoxin under established procedures. Collects and processes samples for media, finished product, and utilities (e.g., water, compressed air).
Executes laboratory activities such as media receiving and growth promotion testing, equipment use, equipment cleaning, and maintaining inventory of supplies. Performs maintenance and calibrations on laboratory equipment.
Supports laboratory and excursion investigations related to the areas of microbiology/sterility assurance. Assists with investigations by providing data and sample history; escalates anomalies or out of specification results to senior staff.
Supports document changes/revisions for microbiology team. Supports internal and external audits by preparing documentation, responding to observations, and participating in audit readiness activities.
Supports cleanroom and controlled environment monitoring activities, including routine sampling and data trending.
Trains other technicians and manufacturing operators in microbiological test methods and use of laboratory equipment.