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Sr, Engineer

Location:
Lares, PR, 00669
Posted:
September 21, 2009

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Resume:

Eng. Gabriel A. Ruiz Pérez

Address: Bo. Buenos Aires Mobile: (787) 509 – 1072

HC02 Box 7123 (787) 632 – 8957

Lares, PR 00669 E-mail: ***************@*******.***

Telephone: (787) 897 – 5268 *****@*********.***

SUMMARY: Chemical Engineer with over nine (9) years of experience in pharmaceutical manufacturing environment. Seeking to obtain a position in a company in which my skills and knowledge can’t only be developed, but also contribute to the best interests of the company.

EDUCATION:

August 1997- May 2003 UNIVERSITY OF PUERTO RICO / Mayagüez Campus

MS in Chemical Engineering

Overall GPA: 3.55 / 4.00 scale Graduate GPA: 3.71 / 4.00 scale

August 1992- May 1997 UNIVERSITY OF PUERTO RICO / Mayagüez Campus

BS in Chemical Engineering Magna Cum Laude

Overall GPA: 3.52 / 4.00 scale Major Field GPA: 3.66 / 4.00 scale

WORK EXPERIENCE:

August 2006 – present APP PHARMACEUTICALS / Barceloneta, PR

PROCESS ENGINEER – ENG DEPARTMENT

Provide routine support to pharmaceuticals manufacturing and processing related issues. Ensure that product and processes are maintained within current industry regulations and standards. Maintain process robustness, process improvement, assurance of product quality, and resolution of process/quality issues.

Analyze data from manufacturing process using advanced methods and tools and provide recommendation for improvement, optimization, or remediation. Generate supporting technical reports

Support scale-up activities related to research and development projects as stability batches and other experimental batches.

Supervise the operation and compliance of the Preventive Maintenance (PM), Calibrations, Work Order (WO) and Plant Drawing systems.

Team Leader during the installation, commissioning, qualification and start up of Filling, Inspection and Packaging equipments. Develop engineering policies and procedures for equipments and processes. Supervise, coordinate and review work of mechanics, operators and/or technicians on a project basis.

WWTP SUPERVISOR / PROJECT ENGINEER – ENG DEPARTMENT

Provide management support to technology transfer projects for the introduction of new products, processes and equipments. Responsible for the generation and tracking of overall project timeline, procurement, installation and qualification of required manufacturing, filling and packaging equipments, documentation generation, cost tracking, etc. Responsible for implementing capital projects from the design and capital procurement phases to the installation and validation phases.

Supervises the Wastewater Treatment Plant operations. Ensure and promote the compliance of federal, local and municipal plant regulations related to environment, health and occupational safety

November 2000 – August 2006 INyX USA, LTD / Manatí, PR

SR. ENVIRONMENTAL / PROJECT LEADER – TCD DEPARTMENT

Provide technical and cost analysis support to Business Development organization during the initial assessment of new potential business opportunities.

Technical work specialized in the area of environment, health and occupational safety that consists of ensuring, promotes and oversees the health and safety of our associates and of the environment.

Develops / submits regulatory reports and administrates / renews environmental permits required by pertaining agencies, such as EPA, EQB, PRASA, etc.

AVENTIS PHARMACEUTICALS / Manatí, PR

PROJECT LEADER – TCD DEPARTMENT

Manages activities for new and/or existing products, processes and equipments, including document preparation, protocol execution and preparation of final reports as well as Capital Projects.

Provide technical and cost analysis support to management team during the initial assessment phase for the introduction of new product presentations and existing process improvements.

ENVIRONMENTAL ENGINEER – EHS DEPARTMENT

Ensure and promote the compliance of federal, local and municipal plant regulations related to environment, health and occupational safety. Reports to the Manager any possible deficiency in compliance of these regulations, establishing action plans to correct and implement it.

Develops and implements investigations and environmental accidents prevention programs, in addition to establishing, handling and preparing contingency plans for emergency cases.

Supervises the emergency brigade and Wastewater Treatment Plant operations.

PROCESS ENGINEER – OPERATIONS DEPARTMENT

Performs technical troubleshooting (process and equipment) and develop strategies and action plans to eradicate identified root causes.

Identifies, develops and implements productivity initiatives in support of increased productivity, product quality, safety measures and Regulatory compliance FDA, OSHA, etc.

Actively participate in the installation, qualification of new facilities and equipment, and in the transfer and implementation of new process and technology.

SKILL AREAS: Technical knowledge in Formulation, Filling, Inspection and Packaging of Sterile products (vials) and Aseptic areas.

Technical knowledge in production equipment, related to Solid Dosage Operation such as wet granulation and direct compression, blending, coating, printing and filling/packaging lines.

Bulk Manufacturing Operation (creams, lotions, ointments and solutions) such as formulation vessels, mixers, transfer pumps, milling and filling/packaging lines.

Familiar with computerized automated production, packaging, material handling, utilities and building support systems.

Applied knowledge and understanding of FDA, EPA, OSHA, EQB, PRASA, NFDA, DOT and other applicable regulations.

Knowledge of general management procedures and skills in the pharmaceuticals industry, GMPs, SOPs, federal and state regulations.

Strong leadership and supervisory skills.

Ability to delegate and manage the project work of others.

Ability to determine when additional external resources are required to solve problems.

Excellent oral and written communication skills in Spanish and English.

Knowledge of computer literate and statistical tools.

PROFESSIONAL Colegio de Ingenieros y Agrimensores de Puerto Rico (CIAPR)

MEMBERSHIPS: National Registry of Environmental Professionals (NREP)

PROFESSIONAL Professional Engineer (PE) License (18422 P.E.)

LICENSES: Registered Environmental Manager (REM 11682)

Wastewater Treatment Plant Operator (U-1943)

REFERENCES: Available upon request



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