Global Lead, Contamination Control & Sterility Assurance

Cytiva

Hauppauge (NY)

On-site

USD 110,000 - 125,000

Full time

5 days ago
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Benefits offered by this job

Bonus eligibility
Medical coverage
401(k) plan
Paid time off

Job summary

Cytiva, a Danaher operating company, is seeking a Senior Manager for Contamination Control & Sterility Assurance to lead strategies across Cytiva manufacturing sites. You will drive programs to ensure regulatory compliance, product quality, and patient safety, while partnering with global teams.

The role reports to the Director of Global CCSA within QARA. It is an on-site role with 20–30% travel and requires extensive experience in regulated life sciences manufacturing and cross-site leadership.

Qualifications

  • Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or related discipline.
  • 10+ years in regulated life sciences manufacturing environments.
  • Experience with contamination control, sterility, microbial control, and environmental monitoring.

Responsibilities

  • Lead contamination control and sterility assurance programs across multiple sites.
  • Drive continuous improvement of environmental monitoring and sterilization practices.
  • Serve as SME for contamination control, sterility, microbial control, and aseptic processing.
  • Support regulatory inspections, customer audits, and internal quality assessments.
  • Lead investigations, CAPA activities, and risk assessments related to contamination events.
  • Establish and monitor metrics to drive performance and standardization across sites.

Skills

Contamination control
Sterility assurance
Environmental monitoring
CAPA
Regulatory inspections

Education

Bachelor's degree in Microbiology or related field

Job description

Cytiva, a Danaher operating company, is seeking a Senior Manager for Contamination Control & Sterility Assurance to lead strategies across Cytiva manufacturing sites. You will drive programs to ensure regulatory compliance, product quality, and patient safety, while partnering with global teams.

The role reports to the Director of Global CCSA within QARA. It is an on-site role with 20–30% travel and requires extensive experience in regulated life sciences manufacturing and cross-site leadership.

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