1. Rita M. Soto Vargas
120 Dr. Pedro Albizu Campos
Lares P.R. 00669
C.787-224-8138
e-mail:rsoto8146@hotmail.com
SUMMARY:
To obtain a progressively challenging position in the pharmaceutical industry where my experiences as a
validation consultant/specialist can be integrated to the best of my capacity resulting in the highest
benefit for my employer.
PROFESSIONAL EXPERIENCE:
Moriah Engineering Solution Ago 14’ – Nov 15’
Pfizer Barceloneta/Vega Baja
 Automation Validation.
 Develop URS, DS, and DT documents.
 Support execution for PI system. Develop and execute IOQ and Final Validation Report.
Ávila Consulting Services, Guaynabo, Puerto Rico Nov 11’ – Dic’13
Stock room Support
Pfizer Barceloneta/Contractor
 Equipment Spare Parts list preparation and System Updates.
 Support Client in the actualization and maintenance the Spare Parts equipment’s.
Reliability Support
Pfizer Vega Baja/Contractor
 Support Client in the actualization, remediation and maintenance of the Preventive Maintenance
System of the facility.
 Generation and review of Preventive Maintenance System.
 Equipment Spare Parts list preparation and System Updates.
 Generation and review of the Object Forms and Routes Forms.
Validation Specialist
Pfizer Caguas/Contractor
 Develop and executive decommissioning protocols and reports for a phase out/close facility.
 Support to Pfizer Caguas site in the close out strategy and plan execution during the phase out of
the facility.
 Prepare qualification documentation for preventive maintenance, spare part list, calibration, SOP
and Change Request.
URS, San Juan, PR Dec 08’ – Jun 09’
Validation Specialist and Document Specialist
Washington Group Int, San Juan, PR Mar 04’ – Dec 08’
Validation Specialist and Document Specialist
Validation Specialist
 Responsible for the development of Regulatory Validation Documentation used on
thermodynamics, laboratory and process equipment and applications.
 Revise construction drawings to complete Validation Protocols.
 Responsible for MOC coordination.

2.  Prepare IQ, OQ and PQ protocols for execution.
 Engineers Technical Project support assistant.
 Support the Preventive Maintenances system task.
Validation Specialist Special Temperature Studies
 Prepare Validation studies using Validator 2000 software.
 Thermodynamics Validation Studies.
 Create templates and study set-up.
 Prepare monitoring instruments pre and post-calibration including reports.
Lilly Del Caribe Validation Specialist and Document Control Guayama, PR
Commissioning and Qualification (C&Q):
 Responsible of Commissioning Activities including Receipt Verifications, Installation Verifications,
TOP Review and IC and IQ execution for the Building 23 Project.
 Responsible of providing document control assistance on the Project Document Control Center.
Duties include document filing, conversion of originals to PDF copies, allocation of PDF copies
into the Company’s archival system, distribution of copies, and preparation of turn over
packages to be provided to the site and any other document control activities as part of the
closure of the project.
Pfizer Pharmaceuticals Validation Specialist Barceloneta, PR
 Responsible of Commissioning Activities including Receipt Verifications, Installation Verifications,
TOP Review and IC and IQ execution.
 Perform smoke profile tests for aseptic areas (Air Handling Units re-qualification).
 Responsible of Commissioning Activities including Receipt Verification, Installation Verification, TOP
Review and IC and IQ execution for Breathing Air and Plant Air.
Amgen Validation Specialist and Document Control Juncos, PR
 Responsible for IQ/OQ/PQ protocols development and execution activities for laboratory equipment
and utilities qualification.
 Responsible for the calibration and maintenance of instruments.
 Develop commissioning and decommissioning documents, and execution.
 Prepare equipment standard operating procedures and train related personnel.
 Responsible of providing document control assistance on the Project Document Control Center.
Duties include document filing, conversion of originals to PDF copies, allocation of PDF copies into
the Company’s archival system, distribution of copies, and preparation of turn over packages to be
provided to the site and any other document control activities as part of the closure of the project.

3. EDUCATION:
Polytechnic University of Puerto Rico
Environmental Engineering (In progress)
University of Puerto Rico
Bachelor in Science
SKILLS
 Strong experience in Validation of thermodynamics equipment such as ovens, incubators,
refrigerators, dissolution baths etc.
 Strong knowledge of FDA and Safety regulations, OSHA, cGMP's.
 Develop, review and approval of Validation Deliverable such as SOP's, URS, FS, Validation Plans
and assessments.
 Develop and execution of IQ, QQ, PQ Protocols according with regulatory standards and company
policies.
 Develop and implement technical and quality documents including Internal and Suppliers Audits
reports, Corrective and Preventive Actions, etc.
 Microsoft Office including Word, Excel and PowerPoint.
 Proficiency on Validator 2000 Monitoring System Software and Calibration Manager Software.
 Ability to work under pressure and computer oriented.
 Great initiative and team player.
 Maintain professionalism at all times and use discretion when handling confidential data.
Certifications
 Validation Industry Certification
 cGMP's Training Certificate
 Thermodynamics Validation Certificate
 Validator- 2000 Monitoring System Software Certified.
 Six Sigma Training Certification