Description
The Sterilization Engineer will evaluate, validate, and optimize sterilization processes for medical devices and combination products across the product lifecycle. Responsibilities include selecting sterilization methods, developing IQ/OQ/PQ and equipment qualification protocols, performing root-cause analyses and continuous improvements, managing risk and change documentation, supporting audits and regulatory inspections, overseeing contract sterilizers and testing laboratories, and applying statistical and engineering methods to solve complex technical challenges. The role requires a bachelor's, master's, or Ph.D. degree in engineering, science, or a related technical discipline, at least five years of professional experience including three or more years in medical devices, biotechnology, healthcare, or pharmaceuticals, and familiarity with international sterilization and quality standards. The position is based in South San Francisco, California, with a salary range of $109,500 to $203,300 and relocation benefits.
