Contamination Control and Sterility Assurance Sr. Specialist

Cytiva • Permanent • South Carolina, United States • 1d ago

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Contamination Control Specialist is responsible to provide expertise and oversight for sterility assurance at site level; including to develop, implement, and maintain contamination control strategies and sterility assurance protocols as directed by Contamination Control and Sterility Assurance management.

This position reports to the Sr. QA Manager Contamination Control and Sterility Assurance US Region and is part of the Contamination Control and Sterility Assurance group located in Duncan, South Carolina and will be an on-site role.

What you will do:

Responsible for the sterility assurance program at site level. This includes dose audit program and provide expertise for transfer of work and capacity expansion projects.
Monitor and evaluate sterility assurance and contamination control performance, and identifying areas for improvement.
Analyze data and utilize statistical tools to assess process performance and improve outcomes.
Support non-conformance, investigations,CAPAs, and change control processes related to contamination controls and sterility assurance.
Ensure compliance with regulatory requirements and industry standards for sterility and contamination control. Including to conduct risk assessments and develop mitigation strategies related to contamination control.

Who you are:

Bachelor's degree in microbiology, biology, pharmaceutical sciences, or a related field.
Minimum of 5 years of experience in contamination control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.
In-depth knowledge of regulatory requirements and industry standards for sterility assurance and contamination control (e.g., FDA, EMA, ISO).
Proven experience in developing and implementing sterility assurance programs and contamination control strategies.
Strong analytical and problem-solving skills, with the ability to identify and address areas for improvement.

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

Ability to travel occasionally within territory or locations

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

Sterilization Standards and Regulations
Microbiology Laboratory

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info .

Join our winning team today. Together, we'll 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.

For more information, visit .

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 to request accommodation.

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