Mechanical Engineer

Jorge A. Rodríguez Colón

Phone: 787-***-**** / 787-***-****

e-mail: ******************@*******.***

SUMMARY OF EXPERIENCE

Highly skilled and dynamic professional with fourteen years of progressive experience in the pharmaceutical and biotechnology industry as Validation and GMP Compliance, and Quality Engineering Project Leader. Experienced in Pharmaceutical, Solid Dosage, Biotechnology, and Aseptic Manufacturing. Providing consultancy in computerized systems, instrumentation, utilities, process equipment, commissioning, start-up, Regulatory, equipment installation, validation, and Laboratory equipment. Maintain technical knowledge by keeping current on applicable processes, practices, and standard industry methods.

SIGNIFICANT EXPERIENCE

Project Quality Engineering Development and Execution Deliverable: Work directly with Engineering, Construction/Contractors, and QA Validation areas to coordinate daily activities, execution activities and to resolve compliance issues. System/Equipments Engineering Turn Over Packages, System/Equipments walk down Plan and System / Equipments Start-up Plan.

Development and Execution of Validation Program Deliverables: Commissioning, Qualification, Validation Summary Reports, Deviation Reports, Addendums, Amendments, IQ, OQ, PQ, FQ, User Requirements Specifications, System Design & Functional Specification, P&ID Walk-down Verification for the following systems:

• Process Equipment

- Tanks and Jacketed Vessels

- Bio-reactors

- Mixers

- Control Valves

- Heat/Cooler Exchangers

- Filters

- Ultra Filtration / Diafiltration Units

- Autoclaves

- Equipment and Vial Washers

- Filling Equipment

- Depyrogenation Tunnel

- Solid Dosage Oven

- Fluid Bed Dryer

- Process Scales

- CIP / SIP

- Process Transfer Panels

- COP Bath

• Utilities

- Clean Compressed Air / Instrument Air System

- Water for Injection System (WFI)

- Purified Water System

- Plant Steam/Clean Steam System

- Nitrogen System

- Chilled Water/Glycol System

- Utilities Transfer Panels

- HVAC System (Controlled and non-controlled areas)

- Potable Water System

- Electrical Power (Transformers / Switches /MCC/Distribution Panels)

• Facilities/Buildings

- Access Security System

- Fire Protection System

- Data and Communication System

• Computer Related Systems

- BMS System

- PCS (Rockwell)

- PLC (Program Logic Controllers)

- Delta V

SELECTED WORK EXPERIENCE

• Abbott Biotechnology Ltd. (ABL) – Small Volume Parenteral Area (SVP) Project, Barceloneta, PR – July 2009 to present.

Commissioning Lead, at the Abbott Ltd. SVP Project, Baceloneta. Supervised and performed System/Equipments Inspection against engineering design and specifications. Developed and performed with client the P&ID walk down and start-up plans. Supervised commissioning activities and commissioning engineers/technicians, focusing more in time management. Report directly to Fluor and Abbott Commissioning/Construction Management. Responsible for the commissioning activities status as per project construction progress based on schedule and project control progress. Participate in the construction and installation of the utilities in new Small Volume Parentheral (SVP) building. Perform commissioning and validation to equipment, utility systems and facilities for the new building. Work directly with Engineering, Construction/Contractors, and QA Validation areas to coordinate daily activities, execution activities and to resolve compliance issues. Responsible to develop and execute Commissioning and Qualification Protocols. Responsible to review executed Commissioning and Qualification Protocols. Equipment Computer and Control Systems Operational Verification and Qualification as part of the commissioning and qualification executions. Revision and development of Operation and Maintenance SOP’s. Revision and updating of process and P&ID drawings. Experience in the operation of Delta-V automation program.

• Amgen, Juncos – Neupogen / Neulasta AML 7A Expansion and SBUU Projects – April 2007 to July 2009

Construction Engineering Turn Over Package (TOP) Manager, at the Amgen AML 7A and SBUU Expansion Project, Juncos. Participate in the construction and installation of the new utilities control center of the SBUU Area in the following areas: Boilers, Soft Water, Chilled Water, Cooling Towers, Water Tanks, Lift Stations, Compressed Air, Deaerator Pumps, Air Handling Units, Power Substation, Transformers, Switches, MCC and Power Distribution Panels. Work directly with Engineering, Construction, and QA Validation areas to coordinate daily activities, execution activities and to resolve compliance issues. Supervised and performed System/Equipments Inspection against engineering design and specifications. Developed and performed with client the P&ID walk down and start-up plans. Supervised System/Equipments Engineering Turn Over Packages development. Supervised and performed commissioning activities and/with commissioning engineers/technicians, focusing more in time management. Report directly to Fluor and Amgen Commissioning/Construction Management. Responsible for the commissioning activities status as per building construction progress based on schedule and project control progress. Responsible for the commissioning protocols (IV) development. Interaction with the Master Project Data Base System development, population, and information confirmation for the support Amgen Preventive Maintenance Maximo System.

• BMS, Manatí – MSR Project, Manatí, PR – April 2006 to April 2007

Senior Validation Engineer, at MSR Project, responsible for the Manati Syringe Project Utilities (Vacuum, and Cold/Hot Glycol (Budzar Units)) start-up, and commissioning. Conduct trouble shouting as applicable for the system. Supervised commissioning activities (IC, and OC), validation specialist and engineers. Prepared and supported protocols execution activities. Reviewed and approved executed protocol for each system.

Responsible for the MSR Project Process Equipment (Pall Tangential Flow Filtration, Mork CIP/SIP Skid, Floor and Table Scales, Buffer Tank and Portable Vessel Tanks) start-up, and commissioning. Conduct trouble shouting as applicable for the system. Supervised commissioning activities (IC, and OC), validation specialist and engineers. Prepared and supported protocols execution activities (IQ, OQ and CSV). Reviewed and approved executed protocol for each system.

• Abbott Biotechnology Ltd. (ABL) - Humira Project, Barceloneta, PR – April 2005 to December 2006

Senior Validation Engineer Lead, responsible for the Humira Project Clean Utilities (WFI, Clean Steam and Purified Water System) facilities / system start-up, and qualification. Conduct trouble shouting as applicable for the system. Supervised qualification activities (IQ, OQ and PQ’s), validation specialist and engineers. Prepared and supported protocols execution activities. Reviewed and approved executed protocol for each system. Prepared amendment for applicable system as per Abbott requirements.

Responsible for the final documentation and closure and some final execution of ABL Laboratory equipments, and Manufacturing Equipments such as Refrigerators, Freezers, Bio-safety Cabinets, and Scales

• Merck Sharp & Dohme – Project Manager, ALPHA TECH INC., Arecibo, PR – April 2004 to April 2005

Responsible for supporting all capital project qualifications. Experience on proposal development. Supervised qualification activities and validation engineers, closely focus in time management. Prepared and performed IQ’s, OQ’s, and PQ’s, CSV and Validation reports as well as validation plans for critical system complying with FDA and Merck specification and standard requirements.

• Pharmacia – Validation Project Leader, ALPHA TECH INC., Arecibo, PR – February 2003 to April 2004

Supervised qualification activities. Ensured all employees adhere to cGMP, safety, and environmental regulations. Coordinated the support activities with other departments such as maintenance, quality, and production. Prepared and performed installation, operational and performance qualifications, and validation reports as well as validation plans for critical system complying with FDA and Pharmacia Corporate Standards.

• Pharmacia – Utilities Supervisor, Barceloneta, PR – April 2002 to February 2003

Supervised the utilities operation including WFI system, purified water, clean steam system, cooling systems, chilled water system, HVAC units system and controls, boilers/plant steam, compressed air system, hot water system, water pre-treatment, emergency power plant, nitrogen system, and waste water. Ensured all employees comply with cGMP, safety, and environmental regulations. Coordinated projects to upgrade and strengthen utilities infrastructure. Coordinated maintenance work at utilities, chemical, and pharmaceutical operations during night shift. Coordinated HVAC work at utilities, chemical, and pharmaceutical operations.

• Pharmacia – Critical Utilities Engineer, Barceloneta, PR – April 1998 to April 2002

Participated in the design phase of the critical utility systems and parenteral areas. Developed Critical Utility System Monographs which described the critical utility system, its design specification, routine monitoring/testing requirements and operational/testing SOP’s. Participate in Commissioning and start-up of parenteral areas and critical utility systems. Prepared and performed the qualification protocols (IQ’s, OQ’s, and PQ’s) for critical utility systems and parenteral operation complying with VMP and FDA standards. Coordinated support activities with other departments such as maintenance, quality and production. Worked closely with the quality control department in the routine monitoring program to ensure critical utility systems maintain quality and reliability standards in addition to maintaining validation life cycles. Performed investigations with quality control department when out of specifications results reported by QC laboratories. Prepared and reviewed change control pertaining to critical utility systems and manufacturing processes and conducted qualification studied as consequence of the change control program. Worked closely with utilities department conducting troubleshooting to situations involving critical utility equipments. Conducted Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).

EDUCATION

• BS – Mechanical Engineering, Polytechnic University of P.R., 1995

• Fully Bilingual – English/Spanish Language

TRAINING AND SEMINARS

• Equipment Qualification

• Validation Safety Guidelines

• Validation Project Management

• Good Documentation Practices at ABL Barceloneta

• Safety, Hazard Communication and Fall Protection Training.

• Basic Concepts in Cleaning and Cleaning Validation

• Programmable Logic Controller

• Computer Related System Validation

• Preparation of Parenteral Medication Technology at Memphis State University

• More Effective Supervisor

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