Sr. Sterilization Engineer

Summary:

As a subject matter expert, candidates must be capable of driving Ethylene Oxide Sterilization (EtO) projects from start to end for both simple medical equipment and complex medical devices with or without external support. Candidates are responsible for formulating, designing, and performing the Ethylene Oxide Sterilization (EtO) validation in accordance with established procedures and regulatory guidelines. Candidates will also perform the testing of samples using various sterilization platforms while analyzing test results, assisting in troubleshooting and generating the sterilization reports. To be a successful sterilization leader, you should demonstrate good critical thinking and judgment, and great attention to detail. 

Essential Duties/Responsibilities:

• Serves as an expert of EO sterilization.
• Works closely with clients to design the validation plan for hard to sterilize devices. 
• Design complex sterilization study for requalification, batch release, equivalence study, comparative resistance study, product adoption, and full validation. 
• Draft validation protocols, reports, deviations, exceptions, and other relevant regulatory documents.
• Completes work orders based on customer order requests/protocols. 
• Performs testing of biological indicators and records results. 
• Performs inventory and reordering from suppliers. Receives both supplier and customer products. Creates shipping documents when required. 
• Maintains equipment and facility following daily cleaning procedures. 
• Maintains various validation documents, files, and records. 
• Interprets protocols and executes PQ portion of a product validation process. 
• Must be current with all regulations pertaining to EO sterilization.  
• Comply with Quality Management (QMS) procedures and company policies. 
• Responsible for maintaining the validation plan, running cycles, and tracking validation project status. 
• Design an initial training plan for new staff and lead refresher training related to EtO sterilization.
• Works as a leader of the Eurofins sterilization team during clients meeting and represents the site while attending conferences.
• Provides scientific feedback and recommendations for microbiology testing requirements, product inoculation plan, and provides support as a subject-matter expert on validation and R&D testing related to product validation studies.