Skills
•Expert knowledge of sterilization science and sterility assurance, including sterility assurance level (SAL), overkill and bioburden-based approaches, D-values, and microbial resistance.
•Working knowledge of EtO (ISO 11135), moist heat (ISO 17665), and liquid chemical (ISO 14160) sterilization standards; familiarity with radiation sterilization (ISO 11137) is a plus.
•Strong knowledge of microbiological test methods and standards, including bioburden and sterility testing (ISO 11737-1/-2), biological indicators (ISO 11138), endotoxin testing (USP <85>/<161>, ANSI/AAMI ST72), and cleanroom environmental monitoring (ISO 14644).
•Strong knowledge of medical device quality systems, including risk management, process validation, nonconformance/CAPA, change control, and supplier controls.
•Excellent investigation, root cause analysis, and data analysis skills, with ability to make sound, risk-based product impact recommendations.
•Strong written and verbal communication skills; able to explain microbiological risk clearly to R&D, Operations, auditors, regulators, suppliers, and contract laboratories.
Requirements
•Bachelor's degree in Microbiology, Biology, or a related life sciences or engineering field; Master's degree or certifications such as AAMI Certified Industrial Sterilization Specialist (CISS), RM/SM (NRCM), CQE, or CQA are a plus.
•7+ years of experience in medical device sterilization, microbiology, or quality engineering, including leading sterilization validation and microbiology programs for sterile devices; Class III or implantable device experience is a plus.
•Hands-on experience with validation and routine control of EtO, moist heat, and liquid chemical sterilization processes.
•Experience managing contract sterilizers and contract microbiology laboratories.
•Experience leading microbiological investigations, NCRs, and CAPAs, including effectiveness verification.
•Experience supporting cleanroom manufacturing environments and external audits or inspections.
•Ability to work onsite and cross-functionally with R&D and Operations teams as needed.