Mechanical Engineer

Miguel A. Cabrera Torres

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

Phone 787-***-****

Ciales, PR

Profile

 Positive, Self Stater, Diligent, Team Builder and Results Oriented.

 Respected professional focused in customer satisfaction as a key driver of company goals achievement. Lead by example and ensure the execution of all safety, security, quality and regulatory policies.

 Over eighteen (18) years working with leading companies in the Pharmaceutical and Biotechnology industries.

 Project Manager – Consistently manage and achieved expected outcome in Drawing “As-builts”, Tagging and Building Decontamination Projects.

 Validation Specialist - Succesfully completed projects in the areas of Facilities, Utilities and Equipment Qualification, Engineering Commissioning, Biotechnology Plant Process Qualification, Vendor and Laboratory Quality Audits and Standard Procedure Development.

Areas of Expertise

 Project Management

 Instrument, Pipelines and Devices Tagging

 Mechanical Drawings “As-built”

 SOP’s for Drawings Development and Control

 Clean in Place and Steam in Place Cycles Development and Qualification

 Room Environmental Certifications (Temperature, RH, Non-viable and Viable monitoring)

 Autoclaves and Stability Chambers Cycles Qualification

 Vision Systems and Packaging Line Qualification

 PLC Validation

 Facilities and HVAC Systems Qualification

 Cephalosporin’s and Penicillin’s Building Decontamination

 HVAC, Utilities and Process Assessments

 Standard Operating Procedures Development

 Engineering Commissioning

 Sop’s, Protocols and Report Preparation

 Temperature and Relative Humidity Data Analysis

 System Life Cycle Approach

 Temperature Mapping of Shipping Containers

 Fire protection system commissioning

Professional Experience

Compliance & Integrated Solutions (C&IS) Nov. 2005 to May 2009

Project Leader

Client: Bristol-Myers Squibb, Barceloneta PR Site

Project Manager leading tagging, drawings “As-built” and decontamination projects:

 Lead Decontamination Project for 200,000 sq. ft. Building exposed to penicillin’s and cephalosporin’s products. Successfully finished project with no presence of bio-active residues.

-Developed protocol and reports for the project.

-Key player in the development and implementation of decontamination strategy.

-Monitored companies in charge of deactivation and decontamination of equipment, facilities and utilities.

-Performed GLP Audits to laboratories biding for samples analysis

-Enforced Safety Plan for the complete project.

Successfully completed three hundreds (300) “as-built” drawings and twelve thousand (12,000) tags projects in five buildings at Bristol-Myers Squibb Barceloneta, Puerto Rico.

-Manage a crew of 30 persons during the tagging project.

-Revised all SOP’s of the Engineering Department.

-Provided support and guidance to Engineering Dept. for the compliance and implementation of the Company Validation Strategy.

-Engineering Department met compliance commitment with the plant within the established time timeframe.

DMCG, Inc. July 2008 to August 2008

Validation Specialist

Client: Wyeth Guayama, PR

 Performed commissioning at Wyeth Manufacturing Facilities Upgrade

-Developed, executed, and completed commissioning protocols and reports for Clean Room Technology

-Successfully completed project within aggressive timeframe.

JR Services, Inc. February 2008 to March 2008

Quality Auditor

Client: McNeil Consumer, Las Piedras, PR

 Performed HVAC, Utilities and Process Assessments. Successfully completed improvements to HVAC system of the manufacturing area reducing microbial counts by 70%.

- Prepared assessment report with recommendations.

- Performed non-vial airborne particulate study in the manufacturing area.

- Evaluated HVAC Air flow Design

EVE Group Corp. July 1998 to November 2005

(Formerly Cabrera Validation Services)

Director

Clients: Ortho Biologics, Manatί, PR

Lilly Del Caribe, Carolina, PR

Biovail Laboratories, Dorado, P.R.

 Provided Validation Services to the Pharmaceutical Industry in Puerto Rico, such as; Computerized System Validation and Audits, Utilities Qualification, Manufacturing and Packaging Equipment Qualification, Room Environmental Certification, Change Control and Document Audits.

- Validated New Shipping Container

- Performed Area Classification for Facilities Upgrade

- Reduced by 80% Warm Room Temperature Control Variability Events

- Optimized and Qualified Autoclave Loads

- Optimized and Qualified CIP and SIP Cycles Time

Life Sciences International July 1997 to July 1998

Lead Computer Validation Engineer

Client: Ortho Biologics, Inc.

 Performed validation activities related to utilities and process equipment.

- Developed and executed Installation, Operational, and Performance Qualification protocols for equipment containing computerized systems such as Water Still, Clean In Place System and Bioreactors.

- Bioreactors SCADA Backup and Data Recording System were improved to enhance system security.

ALPHA TECH, INC. October 1994 to June 1997

Senior Validation Specialist

Clients: Warner Lambert Inc, PR

Solopak, Chicago, USA

BOC Gases, Louisiana, USA

Eisai, Japan

 Validation Project Management, Computerized Systems Training, Computerized Systems Vendor Audits, SOP Development and performance of Validation Activities, such as: developing, writing, and executing Installation, Operational, and Performance Qualification protocols for computerized systems such as PLC, Vision Systems, Packaging Lines, HVAC Control System and Manufacturing Equipment. Preparation of validation plans and protocols; analysis of data and preparation of validation reports in accordance with all applicable regulations.

 Provided support to Japanese manufacturing company of industrial equipment. Assisted their customers in the installation and troubleshooting of new equipment for inspection in packaging lines. Developed design documents for auditing and developing Computerized System Documents (QAP, CMP, Specifications, Requirements, IQ/OQ, SOP and Guidelines) at a company site.

- Key player in the development and expansion of Alpha Tech, Inc. (Part of the group of three that started the company)

- Delivered thorough, high quality services in a timely fashion.

- Successfully managed sensitive computer system validation projects until completion of an FDA audit and the subsequent approval of the validation package.

- Successfully lead projects in Chicago, Japan and Switzerland developing validation documents and technical documentation for the customers of a major international inspection machine manufacturer.

- Developed a Computerized System Training Course for a Client company.

John Brown of Puerto Rico, Inc. June 1994 to September 1994

Senior Validation Specialist

Client: Warner Lambert, Inc., Fajardo, PR

 Developed and executed Computerized Systems Validation Guidelines, procedure and protocol. Performed validation activities during the site to meet FDA requirements. Lead project management and validation activities for ten (10) programmable logic controllers in manufacturing, packaging and HVAC equipment. Managed validation activities main product packaging line and Vision Systems.

- No observations were made by the FDA in regard to the computerized system. Client was certified by the FDA after the audit.

DUPONT MERCK PHARMA May 1991 to June 1994

Validation Specialist May 1989 to May 1991

Validation Technician

 Provided technical support to the Oral Solid Dosage (OSD) and Parenteral Areas, assisting in the process troubleshooting and batch qualification. Developed and executed IQ, OQ, PQ protocols for the HVAC, manufacturing equipment and process. Wrote and revised standard operating procedures (SOPs). Reviewed validation protocols for subsequent internal audits. Participated in the Corporate Team to develop validation guidelines for Dupont Merck Pharma.

- Participated in the OSD area start-up for the manufacture of new products, which was completed and delivered ahead of schedule.

- Successfully validated a Courtoy R-100 Computerized Tablet press (IQ,OQ,PQ), increasing final tablet compression over 40%.

- Qualified a new Clean-In-Place (CIP) portable system to improve cleaning cycle time.

- Recipient of the DuPont Merck Excellence Award for the Technical Support Department - 1993.

Education & Leadership

Education:

Bachelor Degree in Science of Mechanical Engineering, May 1988, University of Puerto Rico Mayagüez, Campus, Mayagüez, Puerto Rico.

Leadership:

Cub Scout Master Pack 93; Ciales, Puerto Rico

Boy Scouts of America, Puerto Rico Council

Special Courses & Training

• Allen Bradley PLC’s

• Omron PLC’s

• Validation of Computers Systems

• Qualification and Validation of Systems for Solid Dosage Forms

• Packaging Lines Validation

• Management Skills for Supervisors

• Statistical Process Control

• Clean Room Technology

• Coating Technology

• cGMP trainings

• Kaye Validator

• Climet Particle Counter

• Kaye Dataloggers

• OSHA Regulations

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