| Job Description: | Principal Sterility Assurance Specialist (Solventum) At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You ll Make in this Role As a(n) Principal Sterility Assurance Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Collaborating cross functionally with R&D, regulatory affairs, quality, and internal and external manufacturers to ensure compliance to ISO and FDA requirements for terminally sterilized healthcare products Leading and performing sterility assurance activities and deliverables for both marketed products and new product development projects globally per international and US standards such as ISO 11135, ISO 11137, ISO 14698, ISO 11737, ISO 14644 and others as applicable Leading as the subject matter expert in a minimum of two sterilization modalities Leading and supporting ongoing manufacturing including environmental monitoring and technical leadership for product sterilization requirements Providing sterility assurance support during compliance, regulatory and supplier audits Providing technical expertise for new product development and change management project teams Leading and supporting of timely investigations and root cause analysis related to sterility assurance issues, environmental monitoring excursion events Applying working knowledge of ISO standards, sterility assurance and microbiology principles to assigned processes and products Authoring and revising of SOPs, WI, templates, etc. Leading in new cycle development and strategic sterilization projects Coordinating testing with Microbiology labs for bioburden, endotoxin, environmental monitoring, sterility, and EO residuals Preparing and analyzing trending data for product bioburden and facility environmental monitoring Establishing, leading, and managing major projects to support business initiatives Monitoring and maintaining industry standards, including leading in the AAMI standards development committee Training of sterility assurance staff in technical concepts and sterility procedures Additional qualifications that could help you succeed even further in this role include: Working knowledge of ISO sterilization standards for EO (ISO 11135), Radiation (ISO 11137), ISO cleanrooms (ISO 14644) Strong knowledge of Good Manufacturing Practice (cGMP), Good Documentation Practices (GDP), and experience working in an FDA regulated environment Strong teamwork and communication skills to work effectively on cross-functional project teams including international teams. Strong technical writing skills for developing sterilization validation protocols and test reports Experience with internal and external notified body audits Ability to multi-task and prioritize, strong project management, analytical and problem-solving skills | ||
| Attachments: | 01_Solventum Principal Sterility Assurance Specialist.docx | ||