Background Summary

• Over eighteen (18) years of professional/management experience in positions of increasing responsibility in the pharmaceutical (solid dosage, liquids, and medical device), biotechnology, consumer products and cosmetic industry.
• Strong background in Audits, Project Management, Commissioning, Qualification, Validations, Quality and Regulatory Compliance. Knowledge in FDA regulation, cGMP\'s, GAMP 5, GAMP 4, GxP, CSV, RS PMX MES (DISY, EDB & EBR), SAP, SCADA and Kaye Validator 2000.
• Exposed to FDA industries in Consent decree. Performed cGMP audits, change control program, and GAP Assessment for equipments, computer systems, utilities, facilities and laboratory validations.
• Plans, prioritizes, assigns, supervises, reviews, audits and participate in the work of staff responsible for Commissioning, Qualification and Validation activities for a wide variety of projects. Experience developing full-life-cycle project plans and delivering full-life-cycle commissioning and validation projects.

Experience

2006-Present Independent Professional Services Puerto Rico, Chicago & Mexico areas
Senior Validation Consultant, Validation Compliance

• Project company names: Wyeth Consumer Healthcare Products, Abbott Biotechnology Ltd., AVON Products, GlaxoSmithKline and Sophia Laboratory.
• Project management support for system implementation projects as well as departmental processes. Definition and continuous improvement of the validation. Weekly project status reporting. Responsibility for execution of automation validation studies in accordance with the cGxPs, regulatory requirements, validation master plans, procedures and protocols. Address and track any issues related to the creation, approval, execution and/or final approval of validation documentation.
• Review, analyze, monitor and approval of Qualification and Validation documentation under a FDA’s Consent Decree.
• Responsible to manage, develop and execute User Requirements, Validation Plan, System Design Specifications, Functional Specifications, Configuration Specification, 21 CFR Part 11 Assessment, Risk Analysis, Traceability Matrix, Commissioning, Installation, Operational and Performance Qualification Protocols for RS PMX Manufacturing Execution System (MES), SAP, Achiever Plus, Coater Equipment, SCADA for Critical Systems and Manufacturing, CIP, and Laboratory Systems.
• Work closely with client. Assist Leading tasks, technical services department and project team for project coordination and status report. Generate, review and support deviations corrective plans. Work directly with Engineering, Construction, IT, QA and Validation areas to coordinate execution activities and to resolve compliance issues. Generation, execution and close-out of deviation reports and protocol Amendments.

2000-2006 Confidential
Senior Validation Consultant, Validation Compliance
Project company names: Schering-Plough Products, Boehringer Ingelheim Chemicals, Beiersdorf, Inc., Caraco Pharmaceuticals Laboratory, Inc.
Provide Validation (Third Party) consulting services during the generation and execution of protocols and reports. Review and approval of Commissioning, Installation, Operational and Performance Qualification Protocols, Reports and related documentation for Computerized Systems, Equipment, Laboratory, Utilities and Process Validation fields. Hands on assistance in the creation and implementation of documented evidence through all phases of the validation life cycle. Assist in the review of IQ/OQ/PQ deviations. Support to trouble-shooting activities by providing expertise, recommendations and corrective actions under a FDA’s Consent Decree.

Perform Gap Analysis and compliance audits on existing operations/documentation and supporting the client’s development of a remediation plan to address the deficiencies. Assisting and conducting laboratory compliance assessments, equipment qualification and validation. Assisting in the development of SOPs, calibration programs, preventive maintenance, systems integration, and change control. Work with clients to evaluate systems and operations for compliance against both internal policies and FDA regulatory compliance. 
Responsable to audit and development of the Assessment of the Computer Systems Validation and 21 CFR Part 11 programs to meet hardware and/or software regulatory requirements, including application of 21 CFR Part 11 and specification concepts for new or existing (legacy type) systems.
Responsible to manage, develop and execute of Change Control, Validation Plan, FAT, Commissioning, IQ/OQ Protocols and Summary Reports for Manufacturing, Packaging and Laboratory equipment and systems.
1999–2000 IPR Pharmaceutical, Inc. (AztraZeneca) Canóvanas, PR
Computer Validation Technologist 
Responsible for develop and execute of validation plans, commissioning protocols, systems validation, reports, specifications and Electronic Records/Electronic Signature (21 CFR Part 11) Gap analysis for associated computer systems. Execution of validation tests (FAT, SAT, IQ, OQ, and PQ). 
Work directly with Engineering, Construction, IT, Quality Assurance and Technical Services areas to coordinate execution activities and to resolve compliance issues. Generation, execution and close-out of deviation reports and protocol Amendments. Coordination of Project Meetings.
Review and approval of internal and vendor software development test documentation. Monitoring and evaluation of changes to validated systems to ensure continued compliance posture. Communication to management of the status of validation efforts, resource requirements and issues. Maintenance of validation portfolios to ensure compliance with regulatory requirements for computer based system validation.

1996–1999 Confidential, PR
Computer & Equipment Validation Project Leader
Project company names: McNeil Consumer Healthcare (Johnson-Johnson), Fersinsa Gist-Brocades, Merck Sharp & Dohme Corp., Alcon Laboratories
Provide technical services support for the solid dosage and liquid manufacturing process, including blending, encapsulation, compression, packaging and shipping. Coordinate, prepare and execute commissioning verification, equipment/facilities qualification and process/packaging/cleaning/system validation activities. Process development and optimization. Performs related work or special projects as needed. Follow up Investigation Reports, Exception Investigation Reports and resolving them as applicable. 
Validation projects lead. Functional responsibility for developing, implementing and coordinating validation strategies for computerized systems and equipment. Supervision of 8 validation specialists and engineer professionals. Gave training to operators and consultants for new equipment and manufacturing processes. 
Responsible for manage, develop and execute System Development Life Cycle (SDLC) validation documentation including Validation Plans, User Requirement Specifications, System Design Specifications, Functional Specifications, Confuiguration Specifications, Traceability Matrix, IQ, OQ and PQ protocols, and Validation Reports for Packaging, Granulation, Compression Areas, Laboratories and Utilities. 
Development and execution of validation documentation for the Information Management Systems area including Computerized Site Validation Master Plan and Programmable Devices Security System.
1991–1995 Confidential
Packaging & Validation Engineer
Development and execution of validation plans, protocols, report, and deviations for associated packaging equipment and systems. Monitoring and evaluation of changes to validated equipment to ensure continued compliance posture. Participation in commissioning, qualification and validation execution tests (IQ, OQ, and PQ).
Development and implementation of programs for qualification and certification of packaging equipment under a FDA’s Consent Decree. 
Assessments of impact upon validated equipment of change control notices. Feasibility assessments resulting in implementation of new technology. 
Technical support during FDA inspections and corporate audits.
Execution of trials in coordination with the Research and Development Department for the introduction of new products and modification of existing ones. 
Development, implementation and coordination of industrial engineering projects (motion and time studies, facility layout, production standard studies, and reduce product cost) Revision and improvement of operating procedures. Monitoring and development of packaging production standards.

Education

Bachelor Science of Industrial Engineering

Skills

• Strong knowledge of cGMP’s and FDA regulations and compliance issues. Knowledge of pharmaceutical industry guidelines, trends and practices.
• Strong analytical skills, quick learner, self-starter, multi-task, analytical and creative. Strong leadership and interpersonal skills. Experience at working both independently and in a team-oriented.
• Project management experience. Problem solving. Proactively manage changes in project scope, identify potential crises and device contingency plans.
• Coach, mentor, motivate and supervise project team members and contractors, and influence them to take positive action and accountability for their assigned work. Excellent communication and negotiation skills and a high degree of interpersonal skills.
• Fluent in Spanish and English.
• Training and Seminars Attended: FDA Auditing of Computerized Systems, Quality Assurance and Regulatory Services: 21 CFR Part 11 by EduQuest, Inc., Good Manufacturing Practices (GMP), World Class Manufacturing, PLC and SCADA Validation, Computer Validation, and GAMP 4 (ISPE). Maintenance and Troubleshooting PLC 5 using RSLogix 5 Software, Auto Cad Design and Programmable PLC 5 using RSLogix5 Software.
• Software Skills

RS PMX Manufacturing Execution System (MES), GEDMS Documentum, Kaye Validator 2000 program, MS Word, Excel, Power Point, Lotus, and MS Project.