Process/Validation Engineer

Contact Information

*** ***** ****** ***. ***

Bayamón, PR 00960

Tel.: 787-***-****

Email:

**********@*****.***

Education

Bachelor of Science

Chemical Engineering

University of Puerto Rico

December 2003

Black Belt Certification

On-Going Project

Trainings

Six Sigma Black Belt Training

Good Manufacturing Practices

Good Documentation Practices

Validation: IQ/OQ/PQ Protocols Development & Execution

A Step-by-Step Approach to Process Validation

Failure Investigations for Pharmaceutical Manufacturers

Principles of Cleaning Validation

Utilities Validation

Skills

Proficient in the use of Word, Excel, Power Point, and Visio.

Working knowledge in MATHCAD, Maximo, and Delta V.

Teamwork oriented and strong leadership skills.

Ability to work under minimum supervision.

Fully bilingual (Spanish/English) Excellent communications skills

Self started ability to manage multiples priorities and good ability for problem solving.

Relevant Experience

Validation & Engineering Group - Guaynabo, PR

2004 to Present

Process Engineer / Validation Engineer

• Technical support for tuning/testing of sequences and operational parameters for Micronization Systems and their associated facility equipment.

• Determination of critical process parameters, equipment specifications, and technical support for development, validation, and manufacturing activities. Worked in the creation of process capability mapping, FMEA exercises and process flow diagrams for all existing products.

• Collaborated with new/existing bulk API manufacturing facilities start-up activities such as GMP reviews, safety and process interlocks definition, new product demonstration, new/existing product technology transfer, instrument classification review, SOP review and Process Description trainings.

• Document Development: Users Requirements, Functional Specifications, Validation Master Plans, Installation Qualification, Operational Qualification, Performance Qualification, Traceability Matrix, Gap Analysis and Summary Reports.

• Provide technical support to manufacturing for the utility and equipment validation of new and existing GMP equipment.

• Monitoring, sampling and performing testing required for validating pharmaceutical equipment, systems, process and utilities.

• Organization of validation projects and ensuring that all equipment and materials are available prior to commencement of projects.

• Experience in equipment qualification includes: centrifuges, tanks, compressors, reactors, pumps, heat exchangers, micronization equipment and facilities.

• Experience in Bio-chemical operators supervision.

Eli Lilly and Company – Mayagüez Site

2002 - 2004

Environmental Process Engineer

• Collaborated with new/existing Incineration facilities start-up activities such as CPT (Comprehensive Performance Test) reviews, safety and process interlocks definition, instrument classification review, SOP review, equipment qualification and process description trainings.

• Certification of Hazardous Waste Incineration Training for operators, offered workshops about effective technical presentations.

• Generation and revision of change proposals.

• Generates, perform and close of countermeasure for incidents investigations.

• Implementation of Process Control (SPC and trending analysis).

• Development of User and Functional Requirements for several systems.

• Development, execution and closeout of IQ/OQ/PQ protocols.

Contact this candidate