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Jessica
Claire
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(555) 432-1000,
, , 100 Montgomery St. 10th Floor
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Summary

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.

Skills
  • Demonstrate leadership, Teamwork,
  • Good interpersonal skills, sound, honest, flexible and respectful.
  • Quick learner, proactive.
  • Ability to work independently in a timely manner, making sure the job is done correctly.
  • Knowledge and understanding of technical data, including specifications, schematics, ladder logic and P&ID sheet.
  • Advance computer skills in Microsoft Office, and other software (Autocad, WebCal, WinCaps).
  • Perform system testing using equipment such as, humidity recorders, voltmeters, and ohmmeters and analyze the data result.
Education and Training
Higher Polytechnic University (ISPJAE) Havana, Cuba, Expected in 07/1994 Bachelor of Science : Industrial Mechanical Engineering - GPA :
GESTA Havana, Cuba, Expected in 2003 Clean Rooms And Clean Productions, Applied To The Pharmaceutical Industry Training : - GPA :
STILMAS Settala, Italia, Expected in 05/2004 Operation & Maintenance of Purified Water, Pure Steam & Water For Injection Systems Training : - GPA :
Terra Farma CDMX, Mexico, Expected in 05/2012 Good Practices For Engineering And Maintenance Training : - GPA :
Merck-Millipore CDMX, Mexico, Expected in 11/2012 Liquid Filtration Training : - GPA :
SPIRAX-SARCO EDOMX, Mexico, Expected in 10/2013 Seminary About Devices Used For Steam Systems : - GPA :
T5DC SA De CV EDOMX, Mexico, Expected in 11/2013 SIEVERS 900 TOC Analyzer Corrective Maintenance Training : - GPA :
Grupo ACF EDOMX, Mexico, Expected in 07/2014 Design, Construction & Commissioning of Reactors And Process Tanks Training : - GPA :
Mettler Toledo CDMX, Mexico, Expected in 07/2014 Technical-commercial Training of Micropipettes Raining : - GPA :
T5DC SA De CV EDOMX, Mexico, Expected in 07/2018 M9 TOC Analyzer Corrective Maintenance Training : - GPA :
Experience
MESA SA De CV - Head of Maintenance Department & Plant Manager
City, STATE, 12/2016 - Current

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:

  • Steam plant generation and distribution system.
  • 20 and 30 mtr autoclave.
  • New structure system for lifting the chucks of 20 and 30 mtr.
  • 20 and 30 mtr construction lines.
  • Unveiling machines
MESA SA De CV (commercial Branch) - Head of Engineering Department
City, STATE, 08/2010 - 11/2016

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:

  • Homogenizing tanks.
  • Process tanks with control.
  • Reactor skid, (stirring, emulsion control system).
  • Sulfuric acid dosing system.
  • CIP & SIP Automatic system.
  • Water filtration system for food industry.
  • Process reactor unit.
  • Process Fermenters.
  • Storage tank for PW & WFI System.
  • Soft water storage and pumping system.
Center For Genetic Engineering And Biotechnology - Technical Section Head & Engineering Dpt Head
City, STATE, 07/1994 - 06/2010

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.

Relevant Recognitions.

  • Institutional achievement Title: Development and introduction of new fermentation, immunoaffinity and ion exchange methods that significantly increased the production capacity of Hepatitis B surface antigen for the preparation of the Cuban vaccine HEBERBIOVAC HB in the 1996-1997 campaign.
  • Institutional Achievement of the CIGB.1999: "Establishment of a purification and distribution system of purified water for the Biopharmaceutical Industry".
  • Institutional Achievement Cost sheets for auxiliary systems, 1999.
  • Institutional Achievement of the CIGB, 2002: "Validation of the critical systems of the CIGB Production Plant"
  • Carlos J. Finlay order to the HEBERBIOVAC-HB collective, for the achievement of the WHO certification of the Hepatitis B vaccine, December / 2002.
  • Publication: “Increase in the production capacity of a purified water system for the biopharmaceutical industry ”, Technical news from the laboratory, year 11, Nº 3, Sept/2003, pp 9-10. (ISSN 1618-6915).

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Resume Overview

School Attended

  • Higher Polytechnic University (ISPJAE)
  • GESTA
  • STILMAS
  • Terra Farma
  • Merck-Millipore
  • SPIRAX-SARCO
  • T5DC SA De CV
  • Grupo ACF
  • Mettler Toledo
  • T5DC SA De CV

Job Titles Held:

  • Head of Maintenance Department & Plant Manager
  • Head of Engineering Department
  • Technical Section Head & Engineering Dpt Head

Degrees

  • Bachelor of Science
  • Clean Rooms And Clean Productions, Applied To The Pharmaceutical Industry Training
  • Operation & Maintenance of Purified Water, Pure Steam & Water For Injection Systems Training
  • Good Practices For Engineering And Maintenance Training
  • Liquid Filtration Training
  • Seminary About Devices Used For Steam Systems
  • SIEVERS 900 TOC Analyzer Corrective Maintenance Training
  • Design, Construction & Commissioning of Reactors And Process Tanks Training
  • Technical-commercial Training of Micropipettes Raining
  • M9 TOC Analyzer Corrective Maintenance Training

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