Hector — Engineer Manager / Principal Engineer

Trained in Six Sigma (6S)

Project Engineer, Qualification Engineer, Test Enginner, Project / Facility / Maintenance Engineer

Project Management, Equipment Qualification and/or Commissioning and Qualification (C&Q) Manager, Design Quality Manager, Quality Control and Field Return Manager

Project Development

Responsible for administering the supervisory responsibility in accordance with the organization's policies and applicable laws. Plan and direct all aspect of the Design Quality Engineering activities within the organization. Delivering design quality elements of the APQP RACI (Responsibility/Accountable/Consulted/Informed) for Gate 0-5, by establishing a program review cadence and team that promotes APQP compliance, and that positively impacts new program launch performance. Champion Continuous Improvement of the APQP process, tools and deliverables, and manages Quality Lesson Learned database. Raise the performance of milestone reviews and approvals. Educate and train employees as to their impact on APQP and new product launches.

Led engineering teams in capital projects, automation, reliability, commissioning and qualifications (C&Q) for manufacturing and packaging areas. Involved in custom equipment design and documentation, through engineering leadership as a consultant in the industries.

Equipment Qualification Manager Led effort to sustain and improve programs and activities associated with life cycle of equipment including equipment specification, engineering and qualification including providing technical support to improve equipment reliability. Developed a guideline to improve skills and knowledge of the FDA requirements and International Society of Pharmaceutical Engineers (ISPE) Guidelines as they relate to documenting selection and qualification of equipment and systems in a Current Good Manufacturing Practice (cGMP) environment. Developed cGMP and Standard Operating Procedure (SOP) compliant documents for equipment selection, specification and engineering including User Requirement Specification (URS), Commissioning and Qualification (C&Q), Engineering Drawing. Served as subject matter expert (SME) on manufacturing equipment/systems and instruments qualifications and validations non-compliance issues, protocol discrepancies/deviations, non-conformance (NCR's) and troubleshooting/solving activities. Identified and implemented equipment upgrades/improvements to increase manufacturing efficiency and/or yields

Project Manager Managed projects development, execution and completion including: installation, operational, performance qualifications, and validation reports for different types of facilities, utilities, equipment, and computer systems. Managed the following companies: 1. Pfizer Pharmaceuticals LLC, Barceloneta, Puerto Rico 2. Bristol Myers Squibb Project, Barceloneta, Puerto Rico 3. Bristol Myers Squibb Project, Mayagez, Puerto Rico 4. Abbott Humira Project, Barceloneta, Puerto Rico 5. GlaxoSmithKline, Cidra, Puerto Rico 6. Pfizer, Arecibo, Puerto Rico 7. Pfizer Global Manufacturing, Amboise, France/Japan 8. Wyeth, Marietta, Pennsylvania 9. Wyeth, Dublin, Ireland 10. Merck Sharp & Dhome - Arecibo, Puerto Rico / West Point, Pennsylvania 11. Baxter, Bloomington, Indiana 12. Genzyme, New Jersey/Germany 13. Eisai Machinery, Japan Provided active and proactive support during un-expected events and changes in order to complete project requirements within established time frame. Developed Guideline for Project Management in the Engineering Department

2000 - 2001 GE INTERNATIONAL CONTROLS, Vega Alta, Puerto Rico Project Engineer Managed Preventive Maintenance, Equipment Optimization and Metrology team including creating and designing new way to update production equipment for higher productivity. Recertification of other companies ISO 9000 Optimized manufacturing equipment and facilities with latest technology to improve productivity

Quality Control and Field Return Manager: Managed Ongoing Reliability Test Lab and Field Return department, including the Field Return service department (USA, Puerto Rico & International). Created an environment for testing new product and component. Created tests to accelerate the useful life of equipment with purpose of finding future problems in equipment and anticipate the solution before the client request