Validation Engineer experienced at Pharmaceutical Industries (Regulated Environments). Leader with diversified technical support experience in Validation Process for world class regulated pharmaceutical industries. Commissioning and Qualification processes for equipment of Manufacturing, Packaging, Facilities and Utilities areas. Possess solid working in corrective action/preventive action (CAPA), testing techniques, GMP's and FDA standards and regulations. Demonstrate leadership and interpersonal relationships with coworkers. Effective, efficient, and systematic problem solving skills to face challenges and take business decisions.
Proactive and able to work under pressure, strategic thinker with excellent analytical abilities, a capacity for creativity and innovation, proven ethical leadership skills, teamwork oriented and focus on sustainable business growth.
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of utilities/facilities/equipment problems.
Able in the use of programs such as: MS Office Application, AutoCAD, MATLAB, Rockwell Automation's RS Logix.
Special Projects Pfizer Consumer Healthcare Project Nov 2014/Present The purpose of the project is to commissioning the new Thermal Solar System (Collectors Model G1-50) as part of the Reheat Water System Project at Main Utilities of Pfizer Consumer Healthcare Guayama, Puerto Rico.
The system consists of 30,000 square foot of solar thermal panels, a 60,000 gal in-ground storage tank, 3 solar field pumps, a heat exchanger (HX) pump and a heat exchanger.
Another project consisted in the modifications/upgrade/improvements to the DI Water Automation System (PLC and SCADA) for the Analgesic and Dietary Manufacturing Area.
It is composed of two (2) 4,000 gal storage tanks, serving two (2) loops, four (4) centrifugal pumps, VFD's to adjust pumps speed, two (2) jacketed hydrophobic vent filters (one per tank), sanitary valves (manuals and pneumatics), fittings, instrumentation and a Human Machine Interface (HMI).
Actavis Oxycodone Aug 2014/Nov 2014 The purpose of the project was to circumscribe the Facilities, Utilities and Manufacturing Equipment located in Building B2 that serves the manufacturing of Oxycodone Hydrochloride/Acetaminophen.
Also to understand qualification activities for the Oxycodone Manufacturing Project at the Actavis Company PLC, Manatí, Puerto Rico facility.
Actavis Hydrocodone-APAP Feb 2014/Nov 2014 The purpose of the project was to encompass all the qualification activities and define the qualification strategy necessary for the Phases of Hydrocodone Bitartrate/Acetaminophen Manufacturing Start-Up including Facilities, Utilities and Manufacturing Equipment at the Actavis PLC Manatí, Puerto Rico facility.
Warner Chilcott Actonel Nov 2013/May 2014 The purpose of the project was to reactive the Facilities, Utilities and Manufacturing Equipment located in Building B2 that serves the manufacturing of Actonel.
Also to encompass all the qualification activities and define the qualification strategy necessary for the Actonel Manufacturing Start-Up Project at the Warner Chilcott Company LLC, Fajardo and Manatí, Puerto Rico facilities.
Knowledge of qualification, validation, and verification processes in specified functional area (i.e.
equipment, facilities, and utilities); and experience of diverse commissioning, verification, and qualification documentation (IOQ, PQ, SOP, interim and summary reports) draft, approval, and execution experience.
Maintain excellent communication with supervisors through weekly status reports, participation in department staff meetings, and other forms as needed.
01/2013 to 11/2013
Process Technician OperatorJanssen Ortho LLC － Gurabo, PR
Good organizational and communication skills with emphasis on developing a system of lean manufacturing, through process development and a system of key performance indicators.
Personal responsibility for following safety rules, SOPs, KPI's and cGMP guidelines.
Operates production equipment (Fluid Bed Dryer) required to manufacture pharmaceutical controlled substance products in compliance with cGMPs, SOPs, FDA and DEA guidelines.
Illumination Design with AGI32 and Visual (Lighting Simulation Design Tools).
Develops and manages a business network for existing and future sales prospects through leads and referrals.
M.E.M: Engineering Management Electrical EngineeringPolytechnic University of Puerto Rico, Hato Rey Campus － San Juan, PREngineering Management General business administration processes (finance, accounting, marketing, human resources, etc.) and how they align with engineering management profession. Electrical Engineering
B.S.E.E: Control SystemsControl Systems
English and Spanish
accounting, business administration, communication skills, excellent communication, documentation, English, finance, forms, functional, human resources, IQ, Leadership, Lighting, marketing, meetings, network, OQ, organizational, PQ, process development, processes, project management, Protocols, safety, sales, Simulation, SOP, Spanish, technical assistance, utilities, validation, written skills