Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA

Senior Manager, Contamination Control & Sterility Assurance (CCSA)
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 Senior Manager, Contamination Control & Sterility Assurance (CCSA) is responsible for providing strategic leadership and technical expertise in contamination control, sterility assurance, microbial control, sterilisation, and aseptic processing across multiple Cytiva manufacturing sites. This role drives the development, deployment, and continuous improvement of contamination control strategies and sterility assurance programs that ensure regulatory compliance, audit readiness, operational excellence, and strong quality performance across the manufacturing network while supporting product quality, patient safety, and customer satisfaction.

This position reports to the Director, Global Contamination Control & Sterility Assurance and is part of the Global Quality Assurance & Regulatory Affairs (QARA) organisation, supporting the Filtration Business Unit. This position is located at any Cytiva manufacturing site including Pensacola, FL;
Hauppauge, NY;
Westborough, MA;
Duncan, SC; and will be an on-site role.

What you will doLead contamination control and sterility assurance programs across multiple manufacturing sites, ensuring alignment with Cytiva quality standards, business objectives, and regulatory requirements.

Drive implementation and continuous improvement of contamination control strategies, microbial control programs, environmental monitoring programs, and sterility assurance practices across assigned sites.

Serve as the technical subject matter expert for contamination control, sterility assurance, microbial control, sterilization, environmental monitoring, and aseptic processing.

Provide technical leadership and support during regulatory inspections, customer audits, and internal quality assessments.

Lead investigations, root cause analysis, quality risk assessments, and CAPA activities related to contamination events, environmental monitoring excursions, and sterility assurance issues.

Establish, monitor, and drive performance through contamination control and sterility assurance metrics, trend analysis, risk management, and deployment of best practices across the manufacturing network.

Act as the key liaison between global CCSA strategy and site execution, driving standardization, knowledge sharing, and sustainable business value creation across the manufacturing network.

Who you are Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
10+ years experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences manufacturing environments.

Dem…