Education / Educación: University degree: University Bachelor's degree in microbiology, biotechnology engineering, or related career. 

 

Desirable: Experience in the Microbiology and Sterilization for medical devices.  Knowledge on FDA regulations, ISO 13485, ISO 14644, ISO 14698, ISO 11135, ISO 11137, ISO 10993-7, ISO 17665, AAMI ST 72, TIR 28, TS 13004, and related ISO and AAMI standards.  Operation, validation and adoption sterilization processes. Experience in transfer or new product introduction projects.

 

Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):  Preparation of microbiological cultures. Aseptic techniques. Environmental and microbiological testing: related to monitoring of controlled areas, water, product bioburden.  Preparation and testing of biological indicators for sterilization processes

 

Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/English (Advanced)

                                                              

Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:  Basic Microsoft Office package: Advanced MS Project: Intermediate MS Visio: Basic Minitab: Basic

 

Qualifications / Cualificaciones:  Drive for Results Planning Organizational Agility Listening Decision Quality  Problem Solving

 

Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

Plan, coordinate and monitor the environmental monitoring program of controlled environment rooms, laundry, laminar flow hoods, air and water systems. Coordinate routine microbiology analysis with external laboratories.  Coordinate with vendors such as sterilizers and external microbiology laboratories, for different special testing requirements. Support/lead sterilization projects. Support or plan and execute cost and/or time effective continuous improvement initiatives for the Microbiology Lab and the routine activities performed.  Plan and lead microbiological validations. Plan, coordinate or perform the dose audits and bioburden programs. Support or lead sterilization process requalifications or/and Annual Sterilization Assessment. Support and execute assessments related to sterilization processes Develop new microbiology methodologies for the Microbiology Laboratory.  Execute change orders.  Approve and support validations and risk analysis Support or lead Microbiology investigations related to NCEs, OOTs, IACAs and CAPAs. Product release support regarding events related to sterilization parameters or deviation events. Support/lead impact assessments related to changes that could affect the effectiveness of the sterilization process.  Create Purchase Orders for services, supplies and others, and verify invoice payment. Ensure availability of laboratory supplies, product samples, and culture media to perform microbiological and sterilization testing.  Coordinate and perform Training Programs for GMPs.