Senior Contamination Control & Sterility Lead

Radiometer; Puerto Rico; Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Health benefits

Competitive compensation

Zusammenfassung

Cytiva, a Danaher operating company, seeks a Sr. Specialist to drive contamination control and sterility assurance across manufacturing and labs at the Fajardo, Puerto Rico site.

You will lead environmental monitoring, qualification programs, and CAPA investigations to ensure product quality and regulatory compliance. Ideal candidates have a microbiology degree and 5+ years in pharma/biotech contamination control, with ISO standards knowledge and strong data analysis capabilities.

Qualifikationen

• Bachelor’s degree in microbiology or related science.
• 5+ years in contamination control and sterility within pharma/biotech.
• Experience with cleanroom qualification and environmental monitoring.
• Strong data analysis and interpretation of microbiological data.
• Knowledge of ISO 14644, ISO 11137, ISO 11737 and EN 17141; quality systems familiarity.
• Willingness to travel for audits and project activities.

Aufgaben

• Develop and maintain contamination control strategies.
• Lead microbiological lifecycle and qualification activities.
• Oversee environmental monitoring and data trending.
• Investigate contamination events and drive CAPAs.
• Collaborate with cross-functional teams on audits and improvements.

Kenntnisse

Environmental monitoring

Sterility assurance

Cleanroom management

Data analysis

Regulatory compliance

Root cause analysis

Ausbildung

BSc microbiology

Jobbeschreibung

Cytiva, a Danaher operating company, seeks a Sr. Specialist to drive contamination control and sterility assurance across manufacturing and labs at the Fajardo, Puerto Rico site.

You will lead environmental monitoring, qualification programs, and CAPA investigations to ensure product quality and regulatory compliance. Ideal candidates have a microbiology degree and 5+ years in pharma/biotech contamination control, with ISO standards knowledge and strong data analysis capabilities.