Jose Ayala

Jose Ayala has over 15 years of experience in the pharmaceutical industry, specializing in commissioning, qualification, and validation. Jose is currently working as a Senior Validation Engineer at CAI, assigned to Merck in Durham, NC. Their responsibilities include developing documentation for the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment. Jose is also responsible for protocol writing and execution and the development of summary reports at client sites.

Prior to their current role, Jose worked as a Validation Supervisor at TriRx Pharmaceutical Services, LLC for two years. In this position, they prepared qualification protocols for new laboratory equipment and verified gap analysis for equipment specification and tolerance. Jose managed protocol and report development and execution, evaluated required validation testing, coordinated contract commissioning and validation services, and interfaced with internal and external clients.

Before joining TriRx, Jose held multiple roles at Par Pharmaceutical from 2015 to 2019. Jose first worked as a Project Engineer, where they prepared qualification protocols for new laboratory equipment and developed JOB plan procedures for analytical laboratory equipment. Jose then served as a Senior Qualification Specialist, where they continued to develop JOB plan procedures and verify gap analysis for equipment specification and tolerance. In this role, they provided high-quality service based on good documentation practices and offered technical support to help customers comply with regulatory agencies.

From 2006 to 2015, Jose served as the President of Qualification and Maintenance Services, Inc. As a hands-on analytical chemist, they improved, developed, validated, and troubleshooted test methods. Jose also prepared validation protocols for new laboratory equipment and conducted inspection, sampling, and testing of finished products and intermediates.

Before that, Jose worked as the Worldwide QC Laboratory Capacity Manager at Cordis, LLC from 2003 to 2005. Jose was responsible for strategic laboratory planning in Puerto Rico, New Jersey, and Italy to meet production schedules. Jose ensured compliance with good manufacturing practices, proper laboratory staffing, and provided guidance and support to resolve deviations and corrective actions.

Jose also served as the Operation Manager at R&J Consulting Corp from 2002 to 2003. In this role, they provided technology and validation support for pharmaceutical projects under FDA consent decree and prepared proposals for new management projects.

Earlier in their career, Jose worked as a Laboratory Team Leader at Lilly del Caribe, Inc. from 1998 to 2002. Jose was responsible for automobile validation, analytical laboratory operations, and supervising a team of technicians and chemists. Jose also worked as a Senior Scientist at Chemsource from 1997 to 1998, where they transferred R&D laboratory analytical methods to QC and performed IQ/OQ of equipment and validated laboratory procedures.

Jose's career began at Warner Lambert, Inc. in 1996, where they worked as a Laboratory Supervisor. Jose was responsible for raw material and finished goods analysis, supervised a team of chemists, and participated in training and development initiatives.

Jose started their career at Merck Sharp & Dohme in 1984 as a Project Chemist and Laboratory Supervisor. Their responsibilities included conducting validation procedures and documentation for routine analysis and developing training guides.

Overall, Jose Ayala has gained extensive experience in pharmaceutical commissioning, qualification, and validation throughout their career. Jose has worked in various roles, demonstrating their expertise in developing documentation, managing protocols and reports, verifying equipment specifications, ensuring regulatory compliance, and providing technical support.

Jose Ayala has a Bachelor of Science (BS) degree in Chemistry from the Universidad Interamericana de Puerto Rico. In addition, they have obtained a certification in Project Management Foundations from LinkedIn in January 2022.