Senior Contamination Control & Sterility Lead

Danaher Corporation; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

Cytiva, a Danaher operating company, is seeking a Sr. Specialist in Contamination Control & Sterility Assurance at our Fajardo, Puerto Rico site.

You will drive contamination control strategies, support sterility programs, and ensure regulatory compliance across manufacturing and lab operations. The role provides technical leadership in environmental monitoring, cleanroom qualification, data analysis, CAPAs, and cross-functional collaboration with Quality, Operations, Engineering and audits.

Qualifications

• Bachelor’s degree in microbiology or related field is required.
• 5+ years of relevant experience in contamination control, environmental monitoring, cleanroom management and sterility within pharmaceutical/biotech industries.
• Experience with cleanroom qualification and environmental monitoring programmes.
• Strong data analysis and interpretation of microbiological and particulate data.
• Familiarity with ISO 14644, ISO 11137, ISO 11737 and EN 17141; experience with CAPA, change control and deviation management.

Responsibilities

• Develop, implement, and maintain contamination control strategies and sterility programmes.
• Lead microbiological lifecycle and qualification activities and protocol execution.
• Oversee environmental monitoring, data trending, and CAPA support.
• Investigate contamination events and deviations, applying root-cause analysis.
• Collaborate with Quality, Operations, Engineering and cross-functional teams on audits and improvements.

Skills

Contamination control

Environmental monitoring

Microbiological testing

Cleanroom management

Sterility assurance

Data analysis

CAPA / deviation management

Education

Bachelor’s degree in microbiology or related

Job description

Cytiva, a Danaher operating company, is seeking a Sr. Specialist in Contamination Control & Sterility Assurance at our Fajardo, Puerto Rico site.

You will drive contamination control strategies, support sterility programs, and ensure regulatory compliance across manufacturing and lab operations. The role provides technical leadership in environmental monitoring, cleanroom qualification, data analysis, CAPAs, and cross-functional collaboration with Quality, Operations, Engineering and audits.