Senior Leader, Contamination Control & Sterility Assurance

Danaher Corporation

Hauppauge (NY)

On-site

USD 110,000 - 125,000

Full time

8 days ago

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Job summary

Cytiva, a Danaher operating company, seeks a Senior Manager of Contamination Control & Sterility Assurance to lead global strategies across multiple manufacturing sites. You will oversee microbial control, environmental monitoring, and aseptic processing, ensuring regulatory compliance and strong quality performance to protect patient safety.

Role reports to the Director of Global Contamination Control & Sterility Assurance and supports the Filtration Business Unit.

Qualifications

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.

Responsibilities

Lead contamination control and sterility assurance programs across multiple manufacturing sites.
Drive implementation and continuous improvement of contamination control strategies and environmental monitoring programs.
Serve as technical SME for contamination control, sterility assurance, microbial control, sterilization, and aseptic processing.
Provide technical leadership during regulatory inspections, customer audits, and internal quality assessments.
Lead investigations, root cause analysis, CAPA activities related to contamination events and sterility issues.
Establish and monitor metrics, trend analysis, and best-practices deployment across sites.
Act as liaison between global CCSA strategy and site execution across the network.