Summary Description:
The incumbent is responsible for providing support to Corporate / Division Sterilization Workstream to ensure efficient and timely completion of project deliverables related to sterilization area including, but not limited to new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements, among others.
Responsibilities associated with this position include working with sites interpreting microbiological testing data, monitoring, and maintaining the sterility assurance used in medical device manufacturing.
The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
The candidate must be a senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate.
The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment.

Qualified candidates must possess relevant experience in one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below.
Ethylene oxide sterilization validation and requalification
Bacterial endotoxin test method validation and monitoring
Bioburden test method validation and monitoring
Reusable Medical Devices
Radiation sterilization validation and dose audit management
Controlled environment monitoring

Knowledge, skills, and abilities:
Demonstrates excellent organizational and communication skills.
Results oriented with a strong focus on quality principles.
Excellent technical writing skills with an understanding of good documentation practice. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Experience conducting microbial test method validations and managing projects independently.
Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.
Experience with controlled environment monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization and dose audit management.
Working knowledge of applicable microbiology standards including, but not limited to, FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, CMDR, Medical Device Directive, European Medical Device Regulation and USP.
Working knowledge of applicable regulations and their interpretation within industry.
Knowledge in Project Management skills and Microsoft Project software.
Ability to track milestones and manage projects.
Fully bilingual (English and Spanish)

Education an Experience:
Bachelor's degree in Engineering, Microbiology or similar discipline.
Minimum of 7 years of experience in the medical device and/or pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes.