Principal, Scientist - Global Sterility Assurance

Boston Scientific-posted about 1 month ago
$99,100 - $188,300/Yr
Full-time • Mid Level
Hybrid • Maple Grove, MN
5,001-10,000 employees
Merchant Wholesalers, Durable Goods
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Boston Scientific is seeking a Sterility Assurance Scientist to join our Global Sterility Assurance team. In this role, you will support sterility assurance strategies and contribute technical expertise to product development, manufacturing, and contamination control initiatives. You'll collaborate with cross-functional partners to implement sterilization solutions and maintain compliance with global regulatory expectations.

  • Support sterility assurance activities related to product development, manufacturing processes, and contamination control programs.
  • Assist in sterilization modality selection and product validation strategy, including cycle design and documentation.
  • Contribute to the implementation of best practices for contamination control and aseptic techniques across manufacturing and R&D environments.
  • Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure alignment with regulatory expectations and internal requirements.
  • Participate in internal audits, regulatory inspections, and risk assessments to provide sterility assurance support and guidance.
  • Apply knowledge of terminal sterilization methods (e.g., EO, gamma, moist heat) to solve technical challenges and support new product introductions.
  • Engage with cross-functional project teams to ensure sterility assurance requirements are incorporated early in the development process.
  • Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biomedical Engineering, or a related field (or equivalent experience).
  • Minimum of 5 years' experience in sterility assurance, aseptic processing, or sterile product manufacturing.
  • Working knowledge of terminal sterilization methods (e.g., EO, gamma, moist heat) and microbiological testing.
  • Familiarity with global regulatory requirements related to sterility assurance (e.g., FDA, ISO, ICH).
  • Strong collaboration and communication skills in cross-functional team environments.
  • Master's degree in a relevant scientific or engineering discipline.
  • Experience supporting new product introduction in a regulated industry.
  • Knowledge of contamination control practices in medical device or pharmaceutical manufacturing.
  • Exposure to audits and regulatory inspections involving sterility assurance topics.
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