I'm a Chemical Engineer with over 18 years of experience in the GMP regulated environment (Medical Devices, Pharmaceuticals, Biotechnology, and Bulk Chemicals industries). Committed with excellence and to give high quality services. ▪ Acknowledged on ISO 13485, 9001, 10993, ISTA, ANSI, USP, CFR 21 parts 11, 58, 210, 211, 820, and 1271 ▪ Experienced on equipment qualification, process validation, test method validation, computerized systems validation, aseptic processing and controlled areas (Class 5, 7, and 8), BAS, environmental controls ▪ Experienced on sterilization processes validation and operation (EtO, Gamma Radiation, and Steam) ▪ Experienced on Design Controls through manufacturing for medical devices and biological products ▪ Supplier and Internal Lead Auditor, Project Management

Validation Manager @ Assist in the planning and implementation of validation activities as they relate to both development and commercial products. Cooperation with contract facilities (CMO's), develop and/or review and approve validation documentation. Oversee validation activities to ensure alignment with company policies and objectives. Support and / or lead validation activities for software / computerized systems. Support Management Review and Compliance related activities. Assist and advise other departments on Technnical Support. From February 2014 to Present (1 year 11 months) Senior Validation Scientist @ Validation, Media Fills, and Qualifications for Autoclave, Lyophilization, Liquid Filling, Isolators, Vessels From May 2013 to Present (2 years 8 months) Lexington, Kentucky AreaValidation/Quality Systems Consultant @ From November 2013 to January 2014 (3 months) Puerto RicoSupervisor, Quality Engineering @ From July 2007 to December 2012 (5 years 6 months) Supervisor QUALITY ENGINEERING @ Part of the Quality Department for a biotechnology company on Phase II Clinical trials for a human cell product. Creation and implementation of the Change Control Program. IQ/OQ, Validation, Computer Validation, and Test Method Validation activities (including protocol preparation, oversees execution, tests, and final reports) for Research & Development, Quality Control, and Manufacturing areas. Creation of Validation Master Plans, procedures, and policies. Statistical analysis for laboratory biological testing system. Computer Validation activities for ERP, software, and laboratory equipments and systems. Lead auditor for Suppliers audits. Management of metrology area including calibration, equipment, and supervision. From July 2007 to December 2012 (5 years 6 months) Senior Quality Engineering @ From July 2007 to December 2012 (5 years 6 months) VALIDATION CONSULTANT @ for a pharmaceutical plant at several areas needs like SOP's revision, protocols preparation, audits, and change control. From June 2003 to September 2003 (4 months) PROJECT MANAGER @ In charge of the re-validation an existing main compressed air system servicing a pharmaceutical plant, manufacturing facilities, a chemical plant and laboratories. (Duties: supervision, cost control, document preparation/revision of Master Plans, specifications, protocols, SOP's), execution, and continuous interaction with client to assess any change or need. Validation Consultant for chemical manufacturing and bio-technology operations. This includes Master Plans preparation, Change Control program audit, SOP's revision, etc. From May 2001 to March 2003 (1 year 11 months) SENIOR VALIDATION CONSULTANT @ Supervisor for the Validation Department at pharmaceutical facilities expansion projects, including process areas, laboratories, etc. This included supervision of validation engineers and technicians at office and field duties and interaction with the client to oversee all needs and changes. Safety Process Designer making safety devices sizing evaluation for chemical process operations. In charge of the Computer Validation of the Building Automation Systems at a pharmaceutical plant. Validation Consultant for an engineering department on Change Control projects and new pharmaceutical manufacturing facilities. From December 1999 to February 2001 (1 year 3 months) VALIDATION ENGINEER @ Project Leader for equipment validation and facilities qualifications for new pharmaceutical manufacturing facilities. This includes project management, supervision, and interaction with the client on all needs and changes during the project. Validation and project support at manufacturing areas (including granulation, drying, blending, and compression) and Y2K assessment and validation for medical devices plants (including protocols preparation, statistical analysis, cleaning processes, and training facilitator). Trainer for IQ/OQ and SOP development. From August 1998 to December 1999 (1 year 5 months) Technical Services Specialist, RHONE @ Assure Quality Compliance of Change Control documents, deviations management, process analysis, and troubleshooting. Lead Validation Engineer for equipment and process validation at manufacturing areas (solids, aerosols, and inhalers), packaging, cleaning processes, and utilities systems (i.e., compressed air, process and purified water, nitrogen). This includes protocols development, execution, and final reports preparation for Validations, Qualifications, and Certifications. From February 1997 to August 1998 (1 year 7 months) Quality Engineer @ Evaluate compliance issues and approval/disapproval of Material Review Reports and Change Control documents. Perform equipment and process validation for manufacturing, packaging, and cleaning processes in a medical devices manufacturing plant (including protocol preparation, execution, and final reports for utilities systems (compressed air and purified water), process equipment (filling, packaging, etc.), processes (cleaning, mixing, etc.), facilities (clean rooms Class 100), and laboratory equipment (fume hoods, autoclaves, etc.). Project coordinator for process and manufacturing areas, and the implementation and/or improvement of equipment and processes (including Factory Acceptance Tests, SOP's preparation, training, and apply GMP, ISO 9002, and DOE- Design or Experiment). From July 1994 to February 1997 (2 years 8 months) Engineer Professional Development @ Abbott Training Program with multiple assignments during completion of the EPD program: Technical Services Validation Engineer for the start-up of a new chemical plant (this includes the implementation of systems), Facilities Maintenance Engineer and project coordinator for a medical devices plant, and Process Support Engineer for a fermentation plant (including process studies and monitoring). From July 1992 to July 1994 (2 years 1 month)

Certification, Theology/Theological Studies @ Colegio Teologico debel cari From 2002 to 2005 Chemical Engineering B.S, Chemical Eng. @ University of Puerto Rico From 1986 to 1992 Mayra Salas is skilled in: GMP, Validation, Sop, V&V, Change Control, Medical Devices, Computer System Validation, Biotechnology, Quality Control, Calibration, Pharmaceutical Industry, Manufacturing, FDA, Laboratory, ISO 13485