Your responsibilities will include:
● 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.
Required qualifications:
● 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.
Preferred qualifications:
● 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.
Maximum Salary: $ 188300
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
