Over 25 years of professional work experience in: Specialist and manager of engineering and maintenance department in pharmaceutical and biotechnology industries. work experience in operation, maintenance & control of critical facilities of pharmaceutical industries. experience and knowledge on electrical, mechanical, pneumatic, electronic systems, and pharmaceutical equipment and utilities. Experience in the implementation of validation plans (IQ,OQ & PQ) of critical systems (AC, PW, PS, WFI, Clean Rooms). work experience in integral projects, from design to the final commissioning phase for pharmaceutical industries.
Areas management (Production, Quality, Maintenance and Administration).
Management of production orders, deliveries, materials, spare parts ( PROD and SAE software).
Management of the preventive and corrective maintenance of the plant equipment.
Work with various clients in analyzing problems and developing simplify process strategies.
Monitoring and participation in projects to improve plant equipment:
Implementation of comprehensive projects at the end customer's facilities.
Preparation of plans, sketches and other technical documents required by the branch and headquarters.
Head of integral projects department, from design to the final commissioning phase:
Preventive and Corrective Maintenance of pharmaceutical equipment. Including auxiliary systems.
Assembly of clean rooms for aseptic processes.
Preparation and execution of the validation protocols & reporters of critical facilities (Compressed air, Purified water, Pure steam, Water for injection, HVAC).
Control & monitoring of revalidation steps and deviations of critical systems.
Control & monitoring of the qualifications of autoclaves, ovens, clean rooms of the process areas.
Evaluation of investments in equipment and clean areas, designs of maintenance systems.
Management and control of the Department section, (Maintenance, Auxiliary Systems, Technical Section). Control and coordination of the purchasing management of the engineering department, including requests, discussion of offers with the supplier, technical analysis and final confirmation.
Technical-commercial analysis of offers for spare parts and accessories and investments for the equipment of process, quality control and development areas.
Support and follow-up of international inspections received such as World Health Organization (WHO), Regulatory Authority of Brazil (ANVISA), Regulatory Authority of Colombia (INVIMA), Spanish Private Company (PRAXIS), Regulatory Agency of South Africa, Regulatory Authorities of Russia.
In addition to all the inspections carried out by the national entity of the State Center for Drug Control (CECMED) throughout this work period.
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