Senior Manufacturing Engineer - Validations Resume Puerto Rico - Hire IT People

SUMMARY:

Engineer with extensive experience in process and equipment instrumentation in the Medical devices, Pharmaceutical, Breweries, Waste and Water, Petrochemical, Gas Energy, Energy industries. Solid experience in process analysis and equipment recommendation/installation, equipment commissioning and validation/qualification, project management, technical coordination, scheduling, process characterization and budget control among others. Created and executed validation protocols, troubleshooting, and continuous improvement, among others. Knowledge of FDA Regulations and GMP, IQ/OQ/ PQ, Continuous Improvement. Budget management and control, including purchasing. Bilingual

SKILLS/ABILITIES:

Knowledge in Project, Word, Excel, Power Point, SAP, Agile, Maximo, Oracle, Windchil, AS400, Trackwise, Solidworks and PRO - Engineer

Bilingual: Domain of English and Spanish

Leadership skills when working with groups of people

Served as President in the Rumblebots Special Project

Team Captain member of the Manta Raya robotic team

SPECIALTIES:

IQ/OQ/PQ

Process Characterization

CAPA analysis

Documentation

Final Reports

PPM Documentation

AGILE

ORACLE

MAXIMO

Cleanroom Experience

Utilities/Equipment Validation

Equipment Maintenance

Waste and Water

PRV and Valves Sizing

Project Management

Honeywell Process Products

Honeywell Field Products

Process Instrumentation

Training

Troubleshooting

Critical Aspect Design Review

Ppk, Cpk, and RTY analysis

Peel, Burst and Blue dye testing

Scrap reduction

Medical Device

Pharmaceutical

Breweries/Food and Beverage

Waste and Water

Energy and Power

Aerospace

Sealing equipment

Test equipment

Valves and Actuators

Thermocouples

Pressure and temp. Switches

Honeywell charts/paperless recorders

Web server alarms

Controllers

Air Compressed Systems

Solid,gas and Liquid flow meters

Level Measurement equipment

Process Instrumentation

EXPERIENCE:

Confidential, Puerto Rico

Senior Manufacturing Engineer - Validations

Responsibilities:

Scheduling and planning the Validation process IQ,OQ,PQ creation, execution and approval for new equipment’s such as vacuums, UV automation equipment, ovens, Pull Test, Alloyd Sealing Equipment; due to increase capacity
Planning and Purchasing of equipment’s with suppliers communication.
Improve regular manufacturing lines to COE manufacturing lines for to comply with lean manufacturing.
Implement and validated new fixtures for the manufacturing process to improve quality.
Develop Process Characterization for new equipment’s and processes.
Create and design PFMEA for new manufacturing process.
Design test methods for manufacturing assemblies to assure product meets the products specification criteria using different equipment’s and techniques.
Coordinated the validation process for new equipment’s and fixtures that are used on new manufacturing lines.
Experience working different tasks and projects as the same time.
Create, Review and Approve validations documents.

Confidential

Senior Product and Process Engineer

Responsibilities:

Scheduling and planning the Design process thru the Validation process. Implement the transfer and validation of components from another supplier to Haina Dominican Republic to be manufactured at Confidential Dominican Republic.
Implement and validated new fixtures such as: couling machines, automated blister sealers, Pouch sealers; for the manufacturing process to improve quality.
Develop Process Characterization for new equipment’s and processes.
Create and design PFMEA for new manufacturing process.
Design test methods for manufacturing assemblies to assure product meets the products specification criteria using different equipment’s and techniques.
Experience working directly analyzing Non-conformance reports and CAPA analysis for different parts and processes.
Coordinated the validation process for new equipment’s and fixtures that are used on new manufacturing lines.
Experience working different projects as the same time.

Confidential, Arroyo, PR

Associate Advanced Manufacturing Engineer/Validation Engineer

Responsibilities:

Working with CAPA analysis.
Working resolving NC’s from daily issues in manufacturing lines.
In charge of validations and test activities for cleanroom relayout validation.
In charge of the new cleanroom facilities(Hvac,, utilities, compressed air, electrical, fumes) buildings, equipment’s validations. In charge of perform the different test that have to be done for a Class 8 cleanroom specification.
Working in improvement of the new manufacturing lines layout in the new cleanroom. In charge of the implementation of new fixtures and equipment to increase manufacturing capacity.
Manufacturing Engineer for two different manufacturing units.
Recommendation and installation of humidity and temperature data loggers to comply with FDA standards,

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Senior Manufacturing Engineer - Validations Resume

Puerto, RicO

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