SUMMARY:

• Electrical Engineer with over seventeen years of experience in various regulated environ - ments, such as the Telecom-munication, Biotechnology, Pharmaceutical industries and Medical Devices, to ensure compliance with FDA regulations, Internal Audits and others. Radio Frequency (RF) engineering, knowledge includes site surveys, site evaluation, RF design sheets, and antenna site installation validations.
• Site construction experience includes inspection and close out documents required to launch sites. Engineered several validation and qualification projects. Extensive experience in supervision.

SKILL:

• Solid communication skills
• Team player
• Self-starter
• People oriented
• Excellent organization and data management skills. Highly computer literate
• Utilize MS Office and Internet tools extensively. Work with corporate policies for quality and compliance with regulatory guidance. Fluent in Spanish and English. PsPice
• Matlab
• UNIX computer language
• Visual Basic and Pathloss.

PROFESSIONAL EXPERIENCE:

Confidential, St. Louis, MO

Validation Specialist

• Responsible for the development, execution, revision and reports of qualification Protocols for the Air Pneumatic Mixer, Ross Homogenizer, Korsch, Ackley Printer, Vector VFC-120, Tote Bins and VFC-3 Lab (IQ and OQ tests).
• Prepared and executed validation and/or qualification studies, including Commissioning, Engineering Studies, Technical Reports, Installation, Operational and Process Qualification Protocols, and Summary Reports.
• Cleaning Validation documents for CHT, DHT and Campaign Length.
• Compliance review and assessment of current state of validations in preparation for FDA audit.

Confidential, St. Louis, MO

Validation Specialist

• Responsible for the development, execution, revision and reports of qualification Protocols for the Air Pneumatic Mixer, Ross Homogenizer and Accela Cota (IQ and OQ tests).
• Prepared and executed validation and/or qualification studies, including Commissioning, Engineering Studies, Technical Reports, Installation, Operational and Process Qualification Protocols, and Summary Reports.
• Cleaning Validation documents for CHT, DHT and Campaign Length.
• Compliance review and assessment of current state of validations in preparation for FDA audit.

Confidential,

Validation Specialist

• Responsible for the development, execution, revision and reports of qualification Protocols for the Engel Machine, Staubli Robot, Filling and Close, Depetalling, Sortimat, Hekuma, Scada (IQ and OQ tests).
• Responsible for the development, execution, revision and reports of qualification Protocols for the Air Compressor and Air dryer (IQ and OQ tests).
• Responsible for the development, execution, revision and reports of qualification Protocols for Analytical Balances and Vertex 410 (IQ and OQ tests).
• Responsible for the development, execution, revision and reports of qualification Protocols for Scada System and Soft Water Storage Tank and Pump Skid (IQ and OQ tests).

Confidential, Guaynabo, P.R

Regulatory Specialist

• Responsible for the evaluation of regulatory documents such as FAA, ASR, NEPA and SHPO for telecommunication cell sites.

Confidential, Humacao, P.R

Maximo Specialist

• Responsible for preparing data sheets for new instruments included in the Calibration & Maintenance Maximo Program. Responsible for training personnel involved in the program implementation.

Confidential, Guaynabo, P.R.

Implementation Manager

• Responsible for the evaluation of sites, scope of work (SOW) creation and contractor training for installation.
• Created material budget within the SOW for the X Alarms on the UMTS Node Bs (indoor & outdoor).
• Prepared material quotes to achieve the most cost effective way while also meeting quality standards.

Confidential, Guaynabo, P.R

RF Engineering

• Responsible for RF design sheet creation (RFDS) to support site installation.
• Performed RF site inspection after construction to ensure that elements included in the RFDS were met.
• This included mechanical & electrical tilts, antenna azimuths, color code and quality standards.
• Executed site inspections during cutovers from Centennial equipment to Confidential new equipment including Confidential and Ericsson UMTS node B’s (outdoor and indoor). Created and documented contractor’s procedure for construction.

Confidential, P.R

Maintenance Engineer

• Prepared Service Request for new instruments that must be included in the Calibration & Maintenance Maximo Program. Reviewed and updated standard operating procedures.

Confidential, Vega Alta, P.R

Assembly Supervisor

• Responsible for meeting production schedules, maintaining timekeeping records and monitoring safety, quality and cost objectives. Responsible for training personnel involved in the program implementation.

Confidential, Waco, Texas

Validation Engineer

• Responsible for the development, execution, revision and reporting of Re-Qualification Protocol for Autoclave & Dry Heat Oven. Prepared the calibration of thermocouples and ValProbes instruments that must be included in the execution with the Validator 2000 and Valprobe Program.

Confidential, P.R

Packaging Services and Validation Engineer

• Responsible for the development, execution, revision and reports of qualification Protocols (IQ, OQ and PQ) for bottle and blister lines.
• Equipments executed included: Omega unscramble, Lakso/Merrill Fillers, Lakso Cottoner, Fowler Capper, Heat Induction Sealer, High Speed Checkweigher, Weiller Labeler, Skinetta Casepacker, Print and Apply System, Uhlmman Thermoformers (UPS4 and 1040), 2205 Cartoner, Overwraper Pester, Boekels Checkweigher
• Responsible of training personnel involved in the execution of validation protocols.

Confidential, Guayama, P.R

Cleaning Validation Specialist

• Prepared and executed validation and/or qualification studies, including Commissioning, Technical Reports, Operational and Process Qualification Protocols, and Summary Reports.
• Responsible to validate the procedure used to clean all of the Bifeprunox Tablets manufacturing process equipments ( Fette 2090, Accela Cota 48” and Solution Tanks)
• Monitored and Executed Cleaning Validation exercises on different stage of the manufacturing process (Blending, Compression, Coating and Inspections) for solid dosage

Confidential, P.R

Validation Specialist

• Responsible for the development, execution, revision and reporting of qualification protocols (Commissioning and IQ &OQ) for equipment (Tanks, bench and pump).

Confidential, Barceloneta, P.R

Validation Engineer, Maintenance Engineer, Manufacturing Supervisor

• Participated in the Cleaning Validation efforts for the start-up project in the New Bulk of Humira Facility Confidential.
• Responsible for verifying data outputs for actual conditions of the water for injection (WFI) used as the rinse solvent for the cleaning process of the tanks.
• Prepared Electronic Calibration Requests (Ecar’s) for the new instruments (utilities & processes) that must be included in the Calibration & Maintenance Program. Responsible for meeting production schedules, quality and cost objectives during the start-up.

Confidential

Validation Specialist

• Participated in the Cleaning Validation efforts for the start-up project in the New Bulk of Neupogen Facility Confidential.
• Prepared and executed validation and/or qualification studies, including Commissioning, Engineering Studies, Technical Reports, Installation, Operational and Process Qualification Protocols, and Summary Reports.

Confidential

Packaging Operator

• Responsible for packaging duties according to GMP procedures with existing packaging equipment, including installation services and operator training.

Confidential, San Juan, P.R

MSC and Platform Engineer

• Responsible for data validation and correction from Lan to MSC.
• Conducted studies to verify Microwave antenna coverage prior installation on site. Designed microwave paths using Path Loss program and field validation of the design. Responsible for studies to verify transmission wave to the antennas. FCC liaison for radio frequency permits.
• Responsible for the design, development and testing of RF design for the cellular base station infrastructure.
• Responsible for the Negotiations, Schedule and Close Out Project.
• Supervised and inspected construction activities of the telecommunication towers installed for the Radio Frequency and Microwave antenna of Movistar’s digital cellular phones.