Contamination Control and Sterility Assurance Sr. Specialist
Danaher · Fajardo
QualityFull-timeCompany career page
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Role summary
Cytiva seeks a senior specialist to lead contamination control and sterility assurance programs at its Fajardo manufacturing site. The role involves developing regulatory-compliant strategies, overseeing microbiological testing and environmental monitoring, and driving continuous improvement across quality and operations.
What they're looking for
- Bachelor's degree in microbiology or related scientific discipline
- Minimum 5 years contamination control, environmental monitoring, and sterility assurance experience in pharmaceutical, biotech, or medical device sectors
- Proven expertise with cleanroom qualification and environmental monitoring programs
- Strong data analysis and interpretation of microbiological and particulate monitoring trends
- Knowledge of ISO 14644, ISO 11137, ISO 11737, EN 17141 standards and quality systems including CAPA and deviation management
- Experience with endotoxin, bioburden, sterility, and particulate testing programs (preferred)
- Willingness to travel and work on-site in manufacturing and cleanroom environments
What you'll be doing
- Develop and implement contamination control and sterility assurance strategies aligned with regulatory requirements and quality standards
- Lead microbiological lifecycle activities including test method management, cleanroom qualification, protocol execution, and deviation management
- Oversee environmental and microbiological monitoring programs; analyze and trend data to identify risks and drive improvements
- Conduct investigations into contamination events and out-of-specification results, implementing root cause analysis and corrective actions
- Collaborate with cross-functional teams on GEMBA walks, quality risk management, audits, and continuous improvement initiatives
Privacy & handoff
This role links to Danaher's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.