Über diese Contamination Control and Sterility Assurance Sr. Specialist Stelle bei Danaher
Danaher · Vor Ort · Fajardo, Puerto Rico
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The Contamination Control & Sterility Assurance Sr. Specialist (P2) is responsible for driving contamination control strategies, supporting sterility assurance programmes and ensuring compliance with regulatory requirements and internal quality standards.
The role provides technical leadership for contamination control, environmental monitoring, microbiological laboratory testing, cleanroom qualification, and sterility assurance activities to support product quality, Quality and Regulatory compliance across manufacturing and laboratory operations.
This position reports to the Senior Manager, CCSA and is part of the Global CCSA team located in Fajardo site.
Work arrangement to be confirmed as on-site.
What you will do:
Develop, implement, and maintain contamination control strategies and sterility assurance programmes in alignment with global regulatory requirements and internal quality standards to support product quality, patient safety, and compliance.
Lead and support microbiological lifecycle and qualification activities, including test method management, cleanroom qualification and requalification programmes, protocol execution, technical assessments, deviation management, and report approval.
Provide oversight of microbiological and environmental monitoring programmes, including endotoxin, bioburden, sterility, and non-viable particulate monitoring, while analysing and trending data to identify risks and drive continuous improvement.
Lead investigations related to contamination events, environmental monitoring excursions, deviations, and out-of-specification results, utilizing root cause analysis and ensuring the implementation of effective corrective and preventive actions (CAPAs).
Collaborate with Quality, Operations, Engineering, and other cross-functional teams to conduct GEMBA walks, execute Quality Risk Management activities (including FMEA), support audits and inspections, and advance continuous improvement initiatives.
Who you are:
Bachelor’s degree in microbiology or a related scientific discipline.
Minimum 5 years of relevant experience in contamination control, environmental monitoring, cleanroom management and sterility assurance within pharmaceutical, medical device or biotechnology industries.
Proven experience with cleanroom qualification and environmental monitoring programmes.
Strong capability in data analysis, environmental monitoring trending and interpretation of microbiological and particulate data.
Knowledge of relevant standards, such as ISO 14644, ISO 11137, ISO 11737 and EN 17141, and experience with quality systems including corrective and preventive action, change control and deviation management.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel as required to support site’s contamination control, sterility assurance, supplier audit or project activities.
It would be a plus if you also possess previous experience in:
Experience with endotoxin, bioburden, sterility, and particulate testing programmes.
Experience supporting sterilisation validation, dose audits, or sterility assurance programmes.
Acting as a subject matter expert during regulatory inspections, customer audits, and internal quality audits.
Work Arrangement
This position is based at Cytiva's Fajardo, Puerto Rico site and is an on-site role. The successful candidate will be expected to work regularly in manufacturing, laboratory, and cleanroom environments and collaborate closely with site and global cross-functional teams.
Benefits
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
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