Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA
Danaher Corporation · Duncan, SC, US
a month agoImpress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA role.
Rezi rewrites your resume against Danaher Corporation's job description. Free.
Tailor your resume to this Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA role.
Rezi rewrites your resume against Danaher Corporation's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA posting at Danaher Corporation — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA posting at Danaher Corporation — free, in seconds.
About the Role
The Senior Manager, Contamination Control & Sterility Assurance (CCSA) provides strategic leadership and technical expertise in contamination control, sterility assurance, microbial control, sterilization, 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 to ensure regulatory compliance, audit readiness, operational excellence, and strong quality performance.
Responsibilities
- 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.
Requirements
- 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.
- Ability to travel approximately 20-30%, including domestic and international travel.
Skills
- Contamination control
- Sterility assurance
- Microbial control
- Sterilization
- Aseptic processing
- Environmental monitoring
- Contamination risk management
- Quality systems
- Regulatory compliance
- Root cause analysis
- CAPA
- Quality risk management
- Sterilization technologies
- Terminal sterilization
- Sterilization validation
- ISO 11137
- ISO 11137
- Contamination control strategy (CCS) principles
- Environmental monitoring program governance
Location
- Pensacola, FL
- Hauppauge, NY
- Westborough, MA
- Duncan, SC
Work Type
- On-site
Experience Level
- Senior Manager
- 10+ years experience
Education Level
- Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
- Master's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
Salary/Compensations
- 110,000.00 - 125,000.00 USD
Benefits
- Paid time off
- Medical/dental/vision insurance
- 401(k)
- Bonus/incentive pay
About the Company
- Cytiva, one of Danaher’s operating companies, is dedicated to saving lives through innovation in life sciences, diagnostics, and biotechnology.
- Our work supports customers in fundamental biological research, vaccine development, new medicines, and cell and gene therapies.
- We foster a culture of belonging and continuous improvement, harnessing the Danaher Business System to turn ideas into impact.
- For more information, visit www.danaher.com.
Equal Opportunity
- 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 comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities.