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Senior Manufacturing Engineer Resume

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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

TECHNICAL SKILLS

  • 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

PROFESSIONAL EXPERIENCE

Confidential

Senior Manufacturing Engineer

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

Associate Advanced Manufacturing Engineer/Validation Engineer

Responsibilities:

  • In charge of new equipment/packaging validation. Supervise Jr. Engineers thru the entire process of the validation including: Data analysis and reports.
  • 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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