Role: Project Validation Specialist III Location: Anasco, PR - 610 Duration: 10 Months
Summary Description: 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.