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

Cytiva; Duncan (SC); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Bonus eligibility

Job summary

Cytiva, a Danaher operating company, is seeking a Senior Manager, Contamination Control & Sterility Assurance to lead global programs across multiple manufacturing sites. You will drive contamination control strategies and sterility practices to ensure regulatory compliance and patient safety.

This role requires a track record of leading technical teams in validated environments, and the ability to support regulatory inspections, audits, and CAPA activities while advancing quality and risk

Qualifications

• Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or related field.
• 10+ years in regulated life sciences manufacturing.
• Experience with contamination control, sterility, microbial control, environmental monitoring, and CCS strategy development.
• Experience supporting regulatory inspections, audits, CAPA, and quality risk management.

Responsibilities

• Lead contamination control and sterility assurance programs across multiple sites.
• Drive continuous improvement of monitoring, microbial control, and sterility practices.
• Act as SME for contamination control and aseptic processing.
• Provide leadership during inspections, audits, and internal assessments.
• Lead investigations and CAPA activities for contamination events and excursions.
• Monitor metrics and drive risk management across the network.
• Collaborate between global strategy and site execution to standardize best practices.

Skills

Leadership

Contamination control

Sterility assurance

Regulatory compliance

Quality systems

CAPA

Education

Bachelor's degree in Microbiology/related

Master's degree (preferred)

Tools

Sterilization technologies

Job description

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 Do

• Lead 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.
• Demonstrated expertise in contamination control, sterility assurance, aseptic processing, microbial control programs, environmental monitoring, contamination control strategy development, and contamination risk management.
• Experience supporting regulatory inspections, customer audits, investigations, CAPA programs, and quality risk management activities within regulated manufacturing environments.
• Experience leading technical teams, projects, or cross-functional initiatives in a global, multi-site environment.
• Strong knowledge of quality systems, contamination control principles, and regulatory compliance requirements applicable to regulated manufacturing operations.
• Proven ability to drive quality improvement, operational excellence, and microbiological risk reduction initiatives across manufacturing sites.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel approximately 20-30%, including domestic and international travel.

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

• Master's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Experience developing and implementing contamination control and sterility assurance programs across multiple manufacturing sites or global manufacturing networks.
• Expertise in sterilization technologies, including terminal sterilization, sterilization validation, ISO 11137, ISO 11737, contamination control strategy (CCS) principles, and environmental monitoring program governance.

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.

The annual salary range for this role is 110,000.00 - 125,000.00 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].