Engineer Quality

PROFESSIONAL SUMMARY:

Chemical Engineer and Manufacturing Validations Engineer with over 15 years of experience working in cGMP regulated environments. Quality and Validation experience researching, analyzing, and applying environmental regulations. Creating, maintaining, analyzing and reviewing records; reports, and other documents; for Chemical, Pharmaceutical, Vaccine, Blood Therapy, Food, Radioactive and Medical Device industries. Proficient management, preparing technical reports, Preventative Maintenance, Standard Operating Procedures, and CQV. Developing complete technical and scientific testing systems and methods for investigation for commissioning and validation of equipment and process.

PROFESSIONAL SKILLS AND ABILITIES:

CAD drawing, AF&ID, P&ID

MathCAD, Statistical Software

Project Management

Lean Manufacturing, 5s, Six Sigma

Statistical Analysis, DMAIC

SAP ERP Software

Medical Device (21CFR800)

Quality Risk Management

Clean in Place Systems and COP

Project Management

Electronic Records (21 CFR11)

Strategic Planning

Pharmaceutical Construction

Commissioning & Qualification Plans

Fire Protection Systems (NFPA III)

Change Control / CAPA

Tank Design (ASME Section VIII)

Quality Systems (21CFR820)

Asbestos Abatement

Regulatory Compliance

HAZWOPER 40

PROFESSIONAL WORK EXPERIENCE:

Ascendent LLC – Environmental Science Technician Pacific, WA 01/2019-present

Build Containment areas prior to beginning decontamination work

Prepare hazardous material for removal and storage

Record test data and prepare reports, summaries, and charts that interpret test results

Develop monitoring programs of environmental pollution

Investigate hazardous conditions and spills, collecting samples for analysis

In Home Healthcare – Care Provider Eau Claire, WI 06/2014-04/2018

Worked as a Care Provider for Autistic and Asperger Children

Providing health promotion, counseling and education

Administering medications, wound care and other personalized interventions

Sanofi-Genzyme – Quality Systems Consultant Allston, MA 03/2010-05/2014

Review CAPAs as well as associated documentation in support of the Manufacturing process changes

Oversee the process of change control approval and CAPA analysis from proposal evaluation, through approval, implementation, closure and effectiveness review

Provided guidance to Manufacturing, Quality, and Facilities departments whether proposed changes may be handled through the document change process

Process included cell culture, purification, fill and finish

Sanofi Pasteur – Senior CQV Quality Manager Consultant Swiftwater, PA 01/2009-03/2010

Flu and Meningitis Vaccine, CIP, Vial Washer, Depyrogenation Tunnel, and Vial Filler Project Management, Installation, Commissioning and Validation

Oversee the Building 57 Menactra manufacturing responsible for Commissioning and Start up management of new building facility

Clean Room validation, Boroscope Verification, Develop testing routines and procedures to troubleshoot issues with computer applications and systems

Implement and oversee environmental management and sustainability programs addressing issues such as recycling, conservation and waste management.

Emergent Biosolutions – Senior CQV Quality Engineer Lansing, MI 04/2008-12/2008

Anthrax vaccine storage validation, CIP system validation, WFI validation, and Software Validation

Analyze validation test data to determine whether WFI system have met validation criteria and identify root causes of production problems

Use Kaye Validator 2000 Data Logger for temperature mapping of freezer units. Assemble thermocouples for thermal studies and calibration.

Genentech – Senior CQV Quality Engineer Consultant South San Francisco, CA 03/2007-03/2008

Human Growth Hormone product fill and validation on a Clinical Parenteral Manufacturing Facility

Vial washer, Depyrogenation Tunnel, and Vial Filler commissioning and validation (Software, CSV, IQ, OQ, PQ)

Use Kaye Validator 2000 Data Logger for temperature mapping of freezer units and CIP Validation. Assemble, weld and kneel thermocouples for thermal studies and calibration.

Cleaning Validation including swabbing and biological indicators for CIP System

Perform personnel function such as selection, training, and evaluation

EDUCATION:

University of Wisconsin – Eau Claire Campus Eau Claire, WI

Bachelors of Business Administration in Operation Management

University of Puerto Rico – Mayagüez Campus Mayagüez, Puerto Rico

Bachelor of Science in Chemical Engineering

LANGUAGES:

Fully bilingual in English and Spanish

OTHER PROFESSIONAL EXPERIENCE:

Cardinal Health – Senior Validation Engineer Consultant Albuquerque, NM 06/2006-03/2007

Boston Scientific – Senior Validation Engineer Consultant Miami, FL 01/2006-06/2006

VaxGen – Senior Validation Engineer Consultant San Francisco, CA 06/2005-12/2005

Diagnostic Product Corporation – Validation Engineer Consultant Los Angeles, CA 09/2004-05/2005

Nestlé USA – Senior Validation Engineer Eau Claire, WI 12/2000-09/2004

Raytheon – Senior Engineer Consultant San Juan, Puerto Rico 02/1999-11/2000

Bank Institute Technical College – Instructor Computer Programming Mayagüez, Puerto Rico 1998-1999

Johnson & Johnson – OMJ Pharma – Jr. Project Engineer San Germán, Puerto Rico 1996-1997

Merck & Co – Coop Student Internship Barceloneta, Puerto Rico 1992-1994

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