Engineer Quality Assurance
Resume:
Lymari Hernandez
Bethlehem, PA 18018
Mobile: 610-***-****
***************@*******.***
CAREER SUMMARY
Over ten years experience in the Pharmaceutical and Biotech industry as a
Validation / Quality Engineer, including Computer System Validation.
Excellent performance on the development, execution and review of
validation documentation including lifecycle documents as: User
Requirements, Detail Design and Standard Operating Procedures. Validation
and Quality Assurance experience in equipment, cleaning, utilities, and
computer systems. Knowledge in cGMPs and FDA requirements (including 21 CFR
Part 11). Experience in Environmental Engineering. Development and
procurement of environmental documentation.
EXPERIENCE
NES Global, Pennsylvania
Quality Consultant - Contractor, September 2010 - Present
Client: Auxilium
Quality Assurance Support. Document review and approval of qualification
and validation documentation. Assist in performance of risk assessment to
justify validation approach. Risk assessment review and approval.
Documentation process and management through electronic content
management system.
Validation & Engineering Group, PR
Validation Engineer - Contractor, June 2009 - September 2009
Client: BARD
Development and Execution of Validation documentation (IQ, OQ, and
Validation Reports) for Sepramesh manufacturing equipment (ovens and
refrigerators). Validation performed using Validator 2000 and temperature
recorder devices, including the preparation, calibration of
thermocouples.
Global Automation Partners, PR
Automation/Validation Engineer, November 2006 - October 2008
Clients: Amgen, Eli Lilly
Provided Quality Assurance support to Migration activities (field
installation and qualification), assure compliance with client
specifications and regulatory standards. Manage the post execution review
and closeout of all test protocols executed as part of the Migration.
Evaluation and resolution of test problem reports. Ensure compliance with
regulations and proper documentation. Development of Test and Validation
Summary Reports.
Responsible for the development and execution of the Process Control
System (PCS) IOQs for a Portable Tanks Operations including CIP and SIP
operations. The PCS IOQs consisted of ControlLogix processor level
testing as well as Unit Class testing. The Unit Class Level testing
included Control Module testing, Equipment Module testing, and Equipment
Phase testing. Worked in the development and closeout of exceptional
condition reports of IOQ protocols including (PCS)
Pharmaplan Flaval, P.R
Senior Validation Specialist, November 2004 - October 2006
Client: Amgen
In charge of the development of the Installation Qualification Protocols
for the equipments (skids, tanks, filters, pumps, skids, autoclaves,
refrigerators, incubators and ovens) including standalone systems of the
Epogen Project (Cell Culture and Purification Area). Development and
execution of Installation and Operational Qualification for Utilities
including: Feedwater, Water for Injection and Purified Water systems.
Washington Group, PR
Validation Engineer, August 2000 - October 2004
Clients: Amgen, Pharmacia, Merck Sharp & Dohme, Stryker
Executed Installation Completion Reports for preventive maintenance,
calibration and inventory parts according with cGMP. This documentation
was part modification of an API (Active Pharmaceutical Ingredient),
manufacturing facility. The modification includes the installation of
equipment; bag breaker, reactors, air handling units, motors, valves,
pumps, instrumentation and utilities.
Change Control execution that includes physical inspection (commissioning
activities) of the manufacturing equipment and critical systems
utilities. Also, preparation of reports considering all aspects affected
by the change like: spare parts, calibrations, and preventive
maintenance. This report is either part of the IQ or OQ protocol filed
execution documentation.
Development and execution of IOQ Protocol for laboratory equipment
(Incubator, Refrigerators) using Validator 2000.
Development and execution of Installation and Operational Qualification
Protocols for pharmaceutical equipment including: Twin Shell Blender,
Coating System and Quick Sieve.
Environmental Quality Board
Environmental Engineer, February 2000 - August 2000
Evaluated engineering design projects related with the construction of
water treatment facilities: waste water treatment and pre-treatment plants
and irrigation systems, according with the Environmental Quality Board
Regulations and Standards.? Inspected the waste water treatment plants from
the Puerto Rico Water Company
Ray Architects and Engineers
Environmental Engineer, June 1999 - February 2000
Develop environmental documentation, procure permits and negotiate it with
government regulatory agencies: ARPE, EQB, Health Department among others.
EDUCATION
BACHELOR OF SCIENCE IN CHEMICAL ENGINEERING
University of Puerto Rico, Mayag ez Campus
SPECIAL TRAININGS
FDA Inspections
Readiness for CSV and 21 CFR Part 11:Electronic Records and Electronic
Signatures
Good Manufacturing Practices"Laboratory Equipment Qualification"
Project Controls & Change Management
Lyophilization Processes and Validation Principles
Validation Equipment (Validator 2000)
OSHA 10-hour Occupational Safety and Health
Skills
Computer Application Knowledge: Microsoft (Word, Excel, PowerPoint,),
RSView
Excellent analysis, problem solving, communication and documentation
skills.
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