9 yr experienced Validations and Quality Engineer
Resume:
Steven Padín Aquino, P.E.
Estancias de San Nicolás
Vega Alta, PR 00692-2496
Mobile 787-***-****
Fax 787-***-****
******.*****@*****.***
Summary of Qualifications
• More than twelve (12) years of experience in the Engineering field as a team supervisor, project manager and as a Validations/Qualifications Engineer
• Four (4) years of experience as the Sub-Director and Director of the Arecibo regional office of OMEP (“Oficina para el Mejoramiento de las Escuelas Publicas”) (refer to the Experience section).
• Four (4) years of experience as a Project Manager for major-level Validation capital projects in Pfizer Arecibo (refer to the Experience section).
• Two years of managing experience obtained from the development and administration of a personal business from 1995-97.
• 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.
• Self-learner and Self-improver.
• Ability to work and deliver results under pressure conditions.
• Have a variety of experience in sales and have held management positions in one company.
• Strong background designing, developing and testing computer information systems.
• Experienced as a Computer Validations Specialist developing and executing validation protocols (URS, FDS, FAT, IQ/OQ).
• Experience as a Validation Specialist developing equipment and facilities Installation and Operational Qualification (IQ/OQ) protocols and performing their execution according to good Engineering practices and current Good Manufacturing Practices (cGMP).
• Experienced in the Quality Operations area as a Quality Systems Specialist.
• Highly computer literate and proficient.
• Fully bilingual in English and Spanish.
• Licensed as an Engineer (Professional License) and as a Real Estate Appraiser (EPA License).
Experience
Independent Consultant 2001 to Present
Provide consulting and professional services in the Engineering and Validations areas to diverse customers on demand, including, but not limited to validation services, project management, technical services on automated systems and others.
Validations Consultant Services
• Abbott (Jayuya, PR) – In charge of the Computer Validation of the Systech Vision System installed at the Blister production area. Deliverables: IOQ and PQ Protocols (development and execution).
• Pfizer (Barceloneta, PR) – Assigned to Pfizer Barceloneta as a back-fill resource for the Automation Division on the NUCON 2 System modifications project. Developed 4 Functional Requirement Specifications (FRS) documents as part of the Computer Validation project.
• Wyeth Pharmaceuticals (Carolina, PR) – Responsible as part of the Commissioning and Qualification Team of the Tygacil Shutdown Bundle Projects for the Pre-Commissioning activities such as the retrieval of project submittals, manuals, calibration records (and its generation as required), preventive maintenance guides (and its generation as required), and the execution of the Commissioning and Qualification protocols.
• Ortho Biologics (Manati, PR) - Responsible for the Project Management, Project Planning and full Implementation of the ISPE Commissioning and Qualification Guidelines to the Validation System at the Plant as a Pilot Project looking for a later implementation at Global Level in other Johnson & Johnson sites.
• Schering Plough (Manati, PR) - Responsible for the development and execution of a Special Study verifying the Environmental Conditions compliance of weighing and sampling room 134 at Central Weigh Area at Building 533.
• Ortho Mc Neil Pharmaceuticals (Manati, PR) - Equipments/Systems qualified include: Air Handling Units, Delta Converter/Packager System (Computer Validation), Lee Mixer Tanks and Hirano Coater Machine (Computer Validation).
• Cordis (San Germán, PR) - Development and approval process of the IOQ protocol for the WATERS Empower Chromatographic Manager Software.
• Wyeth Pharmaceuticals (Carolina, PR) - Responsible of developing IQ and OQ Protocols for Computer and Control Systems for Pharmaceutical Industry Processes like Lyophilizers, Air Handling Units (AHU's), Flow Hoods, Autoclaves, Pyrogen-Free Steam Generators and others. Validation protocols were also developed and executed on the mechanical system of the previously mentioned equipment. Responsible for the execution of a Facilities Validation made on the GOBS project.
APP Pharmaceuticals, Barceloneta, Puerto Rico December 2007 to April 2009
Quality Systems Specialist
• Responsible for providing support to the Plant’s Engineering Department with the Calibration System including, but not limited to:
o Plant’s calibration system: calibration certificates approval, and QO Support to Calibration Call Alerts (investigation to out-of-tolerance deviations on critical instrumentation).
o Investigations to incidents involving critical systems that are under the ownership and direct responsibility of the Engineering department.
o Revision and Approval of Engineering Department’s Standard Operating Procedures (SOP).
• Responsible to provide support to diverse Compliance tasks like internal audits, Corporate SOP’s and Policies revisions, investigations and other on-demand tasks.
• Responsible for providing full QO Support to Validation projects.
• Provided support during several plant projects developing and executing qualification protocols and Standard Operating Procedures.
Pfizer Global Manufacturing, Arecibo, Puerto Rico 2002 to 2006
Qualifications Engineer
• Responsible for the Project Management and/or development/execution of the Commissioning and Qualification (C&Q) of Capital Projects such as: Valdecoxib Commercial Campaign phases I, II and III, Exemestane production train phases I and II, Eplerenone New Facilities (pre-start) and Arecibo Drug Products # 3 (ADP-3) new facilities qualification project. Responsible to be site's representative of the Regional C&Q Sub-Team.
• Responsible for the development, execution, and management of Computer Validation projects including PLC and DCS systems for the Plant’s purified water system, HVAC Systems and the diverse equipment from the API plant. Deliverables included: Validation Plans, Business Continuity Plans, IQ and OQ protocols, Traceability Matrices and Final Reports.
Department of Education of Puerto Rico, Hato Rey, Puerto Rico 1997 to 2000
Licensed Engineer II
• Promoted to the Central-level Engineering Department by the Secretary of Education of Puerto Rico. Responsibilities included joining the Engineering Team in the development of Major Budget projects that involve the construction of new schools and major enhancements to existing ones. Also, duties include the Inspection of projects made along with the Municipalities administrations and other projects involving U.S. Federal Funds, like the Hazard Mitigation Project.
• Named by the Administrative Sub-Secretary of the Department of Education of Puerto Rico to perform the management of the agency as Regional Director (Arecibo Regional Office) in an interim basis.
• Performed duties as the agency’s Regional Office (Arecibo, PR) Sub-Director. Duties included:
• Direct supervision of over 300 resources, including office personnel, maintenance teams of plumbers, electricians, soldering experts, septic truck drivers, among others.
• Coordination of duties and tasks among the groups and area supervisors according to the maintenance or repair requests received from the public schools principals or other administrative personnel.
• Administration of the budget supplied by the central administration of the agency and the Department of Education of Puerto Rico.
• Responsible for the coordination and approval for the use of external contractors to perform repairs, construction and maintenance on the schools within the Arecibo region as needed.
Systems by Dionex, Houston, Texas 1989 to 1990
Computer Systems Engineer
• Responsible for the assembly, troubleshooting and sales of computer systems.
Education
Bachelor of Science, Electrical Engineering, Minor: Electronics 1992
University of Puerto Rico, Mayaguez Campus, Mayaguez, Puerto Rico.
Affiliations / Accreditations
• Member of the College of Engineers and Surveyors of Puerto Rico (CIAPR)
• Member of the International Society of Pharmaceutical Engineers (ISPE).
• Certified by the ISPE in the Baseline Commissioning & Qualification Guidelines.
• Electrical Engineering Professional License (P.E.) since 1995.
• Certified on WATERS Empower Chromatography Manager Software (newest version of Millenium32).
• Certified on PLC, SCADA and DCS Validation on a course taken on February 2003.
• Real Estate Appraiser License (EPA) since 2009.
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