Senior Scientist, Sterility Assurance

Your responsibilities will include: 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. 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. 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.