Contamination Control and Sterility Assurance Specialist

What you’ll do:

• Responsible for test method development and validation for Microbiological Methods and Cleaning Methods. Including developing internal training for Microbiology; Responsible to investigate microbiological and sterility failures.
• Responsible to create and maintain Contamination Control Strategy at site level. Including implementing and maintaining a Cleanliness and Hygiene Program; Design transfer (SOPs creation) for routine monitoring, equipment requalification and training for microbiological controls. Maintain and sustain requalification of sterilizers and controlled/qualified areas.
• Support internal and customer audits for test methods development and validation along with contamination control and sterilization.
• Provide SME support for Internal facility, utility requirements, design, validation and selection of materials to be use; including new changes. This includes autoclave, cleanrooms, cleaning and water system validation and qualification; but not limited.
• Support DBS (Danaher Business Systems) initiatives for process improvements and optimization for Microbiology and cleanliness. Support change for best practices.

Who you are:

• A minimum of a BS in Microbiology, Biology, or Environmental Sciences or relative discipline.
• Strong understanding of contamination control principles, cleanroom practices and environmental monitoring.
• Knowledge of regulatory requirements for microbiology testing procedures and endotoxin, particle matter, and viable/non-viable testing.
• Attention to detail, problem-solving abilities, and strong analytical skills.
• Strong written and verbal communication skills are essential.

It would be a plus if you also possess previous experience in:

• Previous experience in a related field, such as quality control, laboratory testing, or manufacturing, is preferred.
• Practical experience with contamination control practices, cleanroom operations, and equipment qualification.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.