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Danaher Corporation Quality Control QC Micro/Sterility Assurance Leader in Westborough, Massachusetts

QC Micro/Sterility Assurance Leader

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

We are looking for a Senior Sterility Assurance professional to lead the QC Microbiology program, reporting directly to the QA Director. This is a key technical role requiring domain expertise related to sterile product validation & manufacturing controls including Terminal Sterilization (e.g. EO, Radiation, Moist heat/steam & X Ray), Aseptic Processing (e.g., sterile filtration and lyophilization), controlled environments and related Microbiology testing. If you have demonstrated experience of building & leading Microbiology and Sterility Assurance programs, then we would love to hear from you.

What you’ll do

  • Support the QA Director with the development and continuous improvements of the Cytiva microbiology and sterility assurance policies & procedures.

  • Responsible for directing cross-functional associates on the implementation of sterility assurance policies and procedures, and monitoring effectiveness.

  • Maintain a sterility assurance program that enables effective stakeholder transparency to program requirements, status of deliverables and any risks.

  • Develop a sterility assurance coaching program for relevant associates who support sterilization processing/release, cleanroom environmental monitoring and sterile validation requirements.

  • Monitor external & internal changes to sterility assurance requirements ensuring any impact to the Cytiva Quality Management System is managed accordingly, including responsibility for supporting Sterile supplier selection & qualification.

Who you are

  • Bachelor’s degree in Microbiology, Biology, or Biomedical engineering discipline with at least 8 years of experience supporting sterility assurance management in medical device, biotech, or pharmaceutical industries. MSc or PhD qualified, desired.

  • Must have a high technical knowledge of ANSI/AAMI, USP & ISO Sterility Assurance & Cleanroom standards, including ISO11135, ISO11137, ISO13408, ISO14644, ISO14698, ISO10993, ISO 17665, ISO16775 with demonstrated experience of implementation responsibility.

  • Have experience of product validations using Gamma, ETO, Moist Heat and Xray sterilisation methods.

  • Experienced in supplier quality performance development of sterile processing suppliers. Sterile supplier auditing experienced, desired.

  • Minimum 8 years leadership experience.

  • Must have effective verbal and written communication, strong networking skills and be experienced in technical reporting.

  • Experienced in Sterility Assurance validation and CAPA management.

  • Demonstrate ability to handle multiple assignments simultaneously and effectively.

Who we are

Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.

Want to know more? Experience life at Cytiva on our Careers website (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !

Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .