Senior Scientist, Sterility Assurance

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
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At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Boston Scientific is seeking a Senior Sterility Assurance Scientist to support core sterility assurance activities within the Global Sterility Assurance team. In this role, you will provide technical support to product development, manufacturing, and contamination control programs under the guidance of senior team members. You will collaborate with cross-functional partners to help implement sterilization solutions and maintain compliance with applicable regulatory requirements.

This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer or take over visa sponsorship for this position. Relocation assistance is not available at this time.

• Support sterility assurance activities for product development, manufacturing processes, and contamination control programs.
• Assist in evaluating sterilization modality options and contribute to product validation activities, including documentation and data review.
• Help implement contamination control and aseptic best practices across manufacturing and R&D areas.
• Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure sterility assurance requirements are understood and incorporated into project activities.
• Participate in internal audits, regulatory inspections, and risk assessments by preparing data, documentation, and technical rationale.
• Apply foundational knowledge of terminal sterilization methods (EO, gamma, moist heat) to support troubleshooting and product development needs.
• Contribute to project teams by providing sterility assurance input and ensuring requirements are addressed throughout development.
• Support Global Sterility Assurance network projects and priorities.

Required:

• Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biomedical Engineering, or related field (or equivalent experience).
• 2–4 years of experience in sterility assurance, aseptic processing, or sterile product manufacturing.
• Foundational knowledge of terminal sterilization methods (EO, gamma, moist heat) and basic microbiological testing principles.
• Familiarity with relevant global regulatory expectations for sterility assurance (e.g., FDA, ISO, ICH).
• Strong communication and collaboration skills in team-based environments.
• Experience working in a ISO 13485 Quality System.

Preferred:

• Master’s degree in a scientific or engineering discipline.
• Experience supporting new product development or process changes in a regulated industry.
• Understanding of contamination control practices in medical device or pharmaceutical manufacturing.
• Exposure to audits or regulatory inspections involving sterility assurance topics.

Requisition

Minimum Salary:$82600

Maximum Salary: $156900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility…