Danaher Corporation Senior Sterility Assurance Engineer in Westborough, Massachusetts
Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry 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. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you’ll do
Technical subject matter expert and oversight of established sterile products as well as new product introduction (NPI) related to Bioprocess.
This role will have deep domain expertise with sterilization science related to development, validation and routine maintenance of sterile products and processes including terminal sterilization (e.g., radiation, ethylene oxide, and moist heat/steam), related microbiology and sterile barrier integrity testing as well as controlled environments and environmental monitoring.
This role is responsible for in-depth knowledge of applicable industry standards and best practices related to sterilization, microbiology and contamination control.
Essential responsibilities include, but are not limited to, the following:
Development, validation, and routine monitoring
Material and configuration compatibility with the selected sterilization modality (includes maximum dose or treatment studies)
Sterilization process lethality and product sterility assurance
Dose mapping validation as related to radiation sterilization
Sterile barrier integrity over the shelf life of the product
Bioburden, Sterility and Bacterial Endotoxin Testing
Contamination control including cleanroom operation, behavior and environmental monitoring as well as manufacturing utilities (e.g., purified water and compressed air)
Develops and executes sterilization validation protocols and prepares final reports.
Reviews and approves validation documentation and test protocols and reports as well as routine monitoring from contract sterilizers , laboratories, and contract manufacturing organizations (CMOs)
Oversight and accountability for sterile product release to distribution
Establishes and continually improve site level procedures related to sterile products, processes, and contamination control. Ensure compliance to applicable Global Quality Procedures and Industry standards
Develops and delivers site level training programs related to sterile products, testing and cleanroom control
Collaborates with Sourcing and Supplier Quality to select, approve and manage sterile suppliers. This includes development of Supplier Quality Agreements, Sterile Processing Agreement and Sterile Contract Manufacturing Agreements
Proactively interfaces with contract sterilizers and laboratories to ensure timely processing, testing, control and resolution of nonconformance or out of specification results
Leads investigation, root cause analysis and CAPA related to sterilization nonconformance reports as well as microbiology and environmental monitoring OOS results
Functions as sterility assurance and cleanroom SME in audits (e.g., customer and regulatory)
Participates as a member of the GEHC Sterility Assurance Center of Excellence (COE) and collaborates with other LS Bioprocess sites as necessary.
Monitors external environment to maintain pace with relevant Industry trends, standards and best practices.
Who you are
Bachelor of Science in Microbiology, Biomedical Engineering or other related engineering disciplines.
Minimum of 6 years of experience in medical products industry directly pertaining to terminal sterilization, microbiology and contamination control.
Ability to develop, validate, implement, and defend business processes that impact sterilization.
Deep domain expertise in sterilization science including: Radiation (gamma x-ray and ebeam) – ISO 11137 Parts 1, 2 and ISO/TS 13004 Ethylene Oxide – ISO 11135; and EO/ECH Residual Testing – ISO 19993-7
Steam/Moist Heat – ISO 17665
Bioburden Testing – ISO 11737-1
Sterility Testing – ISO 11737-2 and USP <71>
When you join us, you’ll also be joining Danaher’s global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
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) .
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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 (https://www.dol.gov/agencies/ofccp/posters) .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 202.419.7762 or email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.