Contamination Control & Sterility Assurance Specialist
Contamination Control & Sterility Assurance Specialist
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Job Description
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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 Specialist is responsible for ensuring the integrity of environmental monitoring quality control testing and sterility assurance processes in a highly regulated medical device environment.
This role involves conducting laboratory analyses maintaining critical equipment managing sterility validation providing training to teams and participating in audits and investigations all while ensuring compliance with industry standards and regulatory requirements.
This position reports to the Contamination Control & Sterility Assurance Team Manager and is part of the Contamination Control & Sterility Assurance team located in Westborough Massachusetts and will be an on-site role.
What you will do:
Perform laboratory analysis of samples using aseptic techniques and following established procedures ensuring full compliance with official compendial and health authority regulations (e.g. USP 788 microscopy method Bioburden BET Environmental Monitoring Water Testing Compressed Gas Testing Quarterly Dose Audit Growth Promotion and Sterility Verification).
Provide support as a Contamination Control and Sterility Assurance Specialist to other sites.
Provide subject matter expertise and training in environmental monitoring QC testing and sterility assurance to peers and cross-functional departments helping to improve team proficiency and ensure adherence to the highest quality standards.
Manage sterilization requests coordinate schedules with suppliers and monitor inventories of samples to ensure continuity in operations.
Possess an in-depth understanding of sterility assurance processes including the validation of sterilization cycles (e.g. EO steam radiation) ensuring full compliance with relevant standards.
Who you are:
Bachelors degree in Biology Microbiology Biotechnology or a related scientific field.
3 years of experience in a Quality Control microbiology laboratory including at least 3 years of performing viable and non-viable sampling in an ISO classified cleanroom environment.
Strong knowledge of aseptic techniques environmental monitoring microbiological QC testing and sterility assurance processes.
Deep understanding of ISO 14644 sterility processes and cGMP (current Good Manufacturing Practices) in medical device product manufacturing.
Experience with Water Endotoxin Bioburden Conductivity and TOC testing.
Travel Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel 10% travel within the Boroughs area.
Must have a valid drivers license with an acceptable driving record
Ability to lift move or carry equipment up to 40lb.
It would be a plus if you also possess previous experience in:
Familiarity with Electronic Management Systems (e.g. Veeva Magic) and proficiency in Excel Word and PowerPoint including trending data analysis (MiniTab Change Point Analyzer).
Proven experience in working with environmentally trending data and analysis.
Strong verbal and written communication skills with the ability to clearly communicate complex data and solutions.
Cytiva a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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 .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law. We value diversity and the existence of similarities and differences both visible and not found in our workforce workplace and throughout the markets we serve. Our associates customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
