1. Steven Padín Aquino, P.E.
Urb. Vista Azul, F-16, 7 St., Arecibo, Puerto Rico 00614-0171
Mobile: (787) 717-4557 email: steven.padin@gmail.com
Interactive online Resume: http://www.linkedin.com/in/stevenpadin
Steven Padín Aquino, P.E. Page 1 of 2
Summary of Qualifications
More than seventeen (18) years of experience in the Engineering field.
More than thirteen (14) years of experience in the Pharmaceutical Industry environment as a quality specialist, team
supervisor, project manager and Validations/Qualifications Engineer.
More than 8 years of experience among project management on several capital projects involving validations (Commissioning
& Qualification of Facilities, Utilities, Systems and Computerized Systems Validation), compliance and engineering change
management. Currently managing multiple solar energy projects through my own professional services corporation.
Four (4) years of experience as Sub-Director and Director of the Arecibo regional office of OMEP (“Oficina para el
Mejoramiento de las Escuelas Públicas”).
Expert in the validation of facilities, systems/equipment, utilities (HVAC, water, nitrogen, air systems), and
computerized/control systems.
Expert in the implementation and application and training on the Commissioning and Qualification (C&Q) methodology
developed by ISPE.
Experienced in the Quality Operations area as a Quality Systems Specialist and as a Sr. Quality Specialist in Pfizer.
Experienced on providing support to Engineering programs such as calibration, spare parts and preventive maintenance.
Experienced on different manufacturing processes as solid dosage, parenterals and API’s.
Able to handle simultaneous projects, and to meet deadlines within a demanding environment.
Willing to assume or delegate responsibilities and perform many tasks at once.
Capable to coordinate work activities of multidisciplinary teams.
Results oriented with proven ability to work independently or in a team group environment.
Hard worker and dedicated person. • Willing to work irregular and or rotating shifts and willing to travel, if required.
Self-learner and Self-improver. • Ability to work and deliver results under pressure conditions.
Strong background designing, developing and testing computerized systems.
Highly computer literate and proficient. • Fully bilingual in English and Spanish.
Licensed as an Engineer (Professional License or PE).
Experience
Pfizer Pharmaceuticals (Barceloneta, PR) – December 2012 to August 2015
(Through Biopharma Consulting JAD Group (Contract / Professional Services))
Senior QO Systems Specialist
Provide support to the Quality Operations department as a Senior QO Systems Specialist on all Automated and Computerized
Systems Validations, Standard Operating Procedures, Engineering Systems (calibrations and Preventive Maintenance and
alerts), Change Request and Interim Reports (through Trackwise) and Main Quality Resource for the SAP implementation
initiative.
Also, provide support to the AMPS Electronic Batch Record implementation (EBR) system for both the drug product and Active
Product Ingredient (API) plants.
Baxter Pharmaceuticals (Jayuya, PR) October to December 2012
(Through Quality Consulting Group, Inc. (Contract / Professional Services))
Validations Consultant
Provide support to the Validations Department on the Expansion Project and Critical Utilities Validations.
Abbott Pharmaceuticals (Jayuya, PR) July to October 2012
(Through EB Validation Services, Inc. (Contract / Professional Services))
Validations Consultant
Commissioning for a Chilled Water Plant, including facilities, a chilled water system, a cooling tower and its control system.
Integra NeuroSciences (Añasco, PR) 2011 to 2012
(Through PharmaBioServ, inc. (Contract / Professional Services))
Quality Engineering Consultant
Remediation project team, of a complete risk assessment of the process validation status, including packaging, shipping,
sterilization, shelf-life and stability.
Merck (Arecibo, PR) 2011
(Through ISO Group (Contract / Professional Services))
Engineer/Utilities
Development, follow-up and test verification of the Change Request for the installation of a Kerosene piping line.
2. Steven Padín Aquino, P.E. Page 2 of 2
Novartis Pharmaceuticals (Humacao, PR) 2010-2011
(Through Validation and Engineering Group (VEG) (Contract / Professional Services))
Validation Specialist
Validation of a modified sampling room including: modifications to an HVAC System, facility qualification for the sampling
room, a new DownFlow Boot (equipment and cleaning validation).
APP Pharmaceuticals, Barceloneta, Puerto Rico (Temporary) 2007 to 2009
Quality Systems Specialist - Provided support to the Plant’s Engineering Department with the Calibration and Preventive
Maintenance System approval and incident investigation. Responsible for providing full QO Support to Validation projects.
Provided support during several plant projects developing and executing qualification protocols and Standard Operating
Procedures.
Abbott (Jayuya, PR) 2007
(Through PHDS Corporation (Contract / Professional Services))
Computer Validation of the Systech Vision System.
Pfizer (Barceloneta, PR) 2007
(Through Moriah Engineering Solutions (Contract / Professional Services))
Resource for the Automation Division on the NUCON 2 System modifications project.
Wyeth Pharmaceuticals (Carolina, PR) 2007
(Through Taratec Development (Contract / Professional Services)
Commissioning and Qualification of the Modifications to the Parenterals Building Facilities and HVAC System.
Ortho Biologics (Manati, PR) 2006
(Through Millennium Group International (Contract / Professional Services)
Project Management, Project Planning and full Implementation of the ISPE Commissioning and Qualification Guidelines to the
Plant’s Validation System.
Pfizer Global Manufacturing, Arecibo, Puerto Rico (Regular Position) 2002 to 2006
Qualifications Engineer
Project Management and/or development/execution of the Commissioning and Qualification (C&Q) of Capital Projects.
Development, execution, and management of Computer Validation projects. Plant’s representative on Pfizer’s Commissioning
and Qualification Regional Sub-Team.
Schering Plough (Manati, PR) 2002
(Through SS Technical Specialists (Contract / Professional Services)
Responsible for the development and execution of a Special Study verifying the Environmental Conditions compliance of a
weighing and sampling room.
Foster Wheeler Corp. (Contract / Professional Services) 2001-2002
• Ortho Mc Neil Pharmaceuticals (Manati, PR) – Qualification of Air Handling Units, Delta Converter/Packager System
(Computer Validation), Lee Mixer Tanks and Hirano Coater Machine (Computer Validation).
• Cordis (San Germán, PR) - Qualification for the WATERS Empower Chromatographic Manager Software.
Wyeth Pharmaceuticals (Carolina, PR) 2001
(Through Kværner Process Corp. (Contract / Professional Services)
• – Mechancal and CSV Qualification for Lyophilizers, Air Handling Units (AHU's), Flow Hoods, Autoclaves and Pyrogen-Free
Steam Generators.
Department of Education of Puerto Rico 1997 to 2000
Licensed Engineer II, Regional Sub-Director and Interim Regional Director
• Sub-Director and Interim Regional Director (Arecibo Regional Office located at Manati, PR).
• Performed the inspection of projects made along with the Municipalities administrations and other projects involving U.S.
Federal Funds, like the Hazard Mitigation Project.
Education
Bachelor of Science, Electrical Engineering, Concentration in Electronics 1992
University of Puerto Rico, Mayagüez Campus, Mayagüez, Puerto Rico.
Affiliations / Accreditations
Member of the College of Engineers and Surveyors of Puerto Rico (CIAPR).
Electrical Engineering Professional License (P.E.) since 1995.
Certified by the ISPE in the Baseline Commissioning & Qualification Guidelines.
Certified on PLC, SCADA and DCS Validation.
Certified by the state (Energy Affairs Administration) as designer and installer of Photovoltaic Energy Generation Systems.
Certified by the state (Office of Permit Management (OGPe)) as an Authorized Professional.
Certified by the state (Office of Permit Management (OGPe)) as an Authorized Inspector of Photovoltaic Projects.