Senior Microbiologist and Sterilization Expert

hace 3 días


Leganés, Madrid, España Empresa Reconocida A tiempo completo

Empresa Reconocida, a renowned medical device company, is seeking an experienced Senior Scientist to support its Laminar business in Santa Rosa, CA. As a Senior Microbiologist and Sterilization Expert, you will play a critical role in ensuring the quality and safety of our products.

The ideal candidate will have a strong background in microbiology and sterilization validation, with experience working in a medical device or pharmaceutical manufacturing facility. You will be responsible for performing complex tests, such as sterilization validation studies, and routine tests, like environmental monitoring sampling of clean rooms, water, and air.

This role requires a high level of technical expertise, strong communication skills, and the ability to work effectively in a team environment. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and company quality standards.

We offer a competitive salary of $120,000 per year, which may vary based on location and qualifications. In addition, you will be eligible for a performance-based bonus, health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and other employee benefits.

As a valued member of our team, you will have the opportunity to grow professionally and contribute to the development of innovative medical devices that improve human health.

Key Responsibilities:

  • Serve as a liaison between the Microbiological Quality & Sterility Assurance (MQSA) team and operations execution team during the development and selection of sterilization modalities, cycle development, and process validations.
  • Work directly with R&D teams to validate and transfer breakthrough technologies to enable future growth and innovations.
  • Drive selection of sterilization modality, validation approaches and validation of the sterilization process for new products, and the sites for execution.
  • Support microbiological aspects of the control and monitoring of the manufacturing environment, including controlled systems such as clean compressed air and purified water.
  • Lead sterilization validations/revalidations studies or special projects as assigned.

Qualifications:

  • Bachelor's Degree in Biology, Biochemistry, Chemistry, Microbiology, Engineering, or a related field of study.
  • A minimum of 4 years of experience with knowledge of medical device company operations, quality standards and GMP regulations of a medical device or pharmaceutical company.
  • Strong technical writing skills, the ability to manage multiple projects simultaneously and the ability to fluently change priorities based upon business need.
  • Experience with the use of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat, etc.).
  • Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.


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