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embecta

Manufactures insulin delivery devices worldwide

Senior Microbiologist

Regulatory & Quality (Life Sciences)Updated on Nov 15
Full-timeDún Laoghaire, Dublin, IrelandNo salary listed

About the Job

Requirements

  • A degree in Microbiology or a related science field is required.
  • At least 5 years of experience in medical device, pharmaceutical, or biotech environments is required.
  • Strong expertise in Good Laboratory Practice (GLP), cleanrooms, validation, and sterilization is required.
  • The candidate must be able to work cross-functionally in regulated environments.

Responsibilities

  • Provide subject-matter-expert oversight for ethylene oxide sterilization, requalification, GLP laboratories, and environmental monitoring.
  • Review and approve sterilization cycles, microbiological data, and product release.
  • Set appropriate microbiological and sterilization quality standards for products and ensure their consistent application.
  • Ensure compliance with ISO 11135, ISO 10993, ISO 13485, and FDA QSR/QMSR.
  • Lead and support root-cause investigations involving microbiological or sterilization-related non-conformances.
  • Maintain laboratory safety, equipment readiness, and compliance with data-integrity expectations.
  • Maintain audit and inspection readiness.

Desired Qualifications

  • Experience in ethylene oxide sterilization is advantageous.

About the Company

embecta

Manufactures insulin delivery devices worldwide

Embecta designs, manufactures, and sells insulin delivery devices such as pen needles, insulin syringes, and safety injection devices for diabetes patients around the world. Its products are used to inject insulin and include disposable components like Nano and Ultra-Fine needles, with a tubeless insulin patch pump once pursued but later refocused on core injection devices. The company differentiates itself as a dedicated diabetes injection devices supplier with a global manufacturing footprint and an established distribution network, originating as a BD spin-off. Embecta aims to grow through strategic expansion, including an announced plan to acquire Owen Mumford to broaden into drug-delivery platforms beyond diabetes.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Parsippany-Troy Hills, NJ
Founded
2022

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