Jose Mora

773-***-****

acyip1@r.postjobfree.com

*** ******* **. ***** ***** 27804

Work Experience

SVP Modernization, Pfizer, Rocky Mount NC June 2016 – Present

Develop Standard Operating Procedures and Batch Records for the new R3 facility o Develop and implement personnel gowning, room classification, commodities flow, personnel flow, cleaning procedures, equipment operation and other procedures for five new filling lines

Work with multiple departments and multiple Pfizer plants to ensure new processes are successful

Quality Engineer, Pfizer, Rocky Mount NC January 2016 – June 2016

Develop Regulatory Commitment Plans to address regulatory observations of the site

laboratories

Develop and implement a periodic review process for all laboratory instruments in the Chemical Quality laboratories, Biological Quality laboratories and Supplier Quality laboratories

Production Supervisor, Pfizer, Rocky Mount NC June 2015-January 2016

Supervised Small Volume Parenteral (SVP) Terminal Sterilization (TS) Filling Production o Supervised seven filling lines producing in excess of 1.5 million units per day o Supervised fifty direct reports including Production Operators, Line Coordinators, Line Technicians and Group Coordinators. Provided continuous feedback, performance coaching and various types of trainings

Audited production documentation such as completed batch record packages and logbooks for quality and cGMP compliance.

o Edited and wrote SOPs and forms for SVP TS to streamline processes and increase compliance

Opened quality investigations and completed CAPAs in TrackWise Management System Product Engineering Intern, Charter Automotive, Milwaukee WI May 2014-May 2015

Developed Finite Element Analyses (FEA) methodology and procedures to use Pro-Engineer to analyze valve train components

o Static stress and fatigue simulations, compound materials, sensitivity and optimization studies, P- Elements of various interpolating polynomials

o Utilized tolerance stack up to optimize designs and verify manufacturing feasibility

Wrote FEA reports and presentations for worldwide OEM customer approval and internal design verification & optimization

Process Engineering Co-Op, Apollo Plastics, Chicago IL May 2012-May 2014

Designed 3-D (Creo/Pro Engineer and Solidworks) models for injection molding including polycarbonate, ABS, polypropylene, nylon and acrylic o Designed mold splits / tool designs for injection molding; wrote CNC programs to manufacture tooling

o Utilized Moldflow simulation and tolerance stack up to optimize designs and verify

Completed manufacturing engineering feasibility drawings and reviewed mold drawings and BOMs to ensure manufacturing feasibility

o Used and interpreted GD&T (ASME) Y14.5-2009 standards

Led multiple process improvement projects that resulted in reduced cost and improved production in molding, painting, pad printing, assembly, and laser etching Education:

Marquette University, Milwaukee, WI May 2015

Honors Bachelor of Science Degree in Mechanical Engineering with a minor in Business

Administration; Cum Laude

Graduated from Walter Payton College Preparatory High School, Chicago, IL Activities and Skills

Fluent in Spanish (reading, writing, and speaking)

ASME (American Society of Mechanical Engineers) Member 2010-Present

ISPE (International Society for Pharmaceutical Engineering) Member 2015-Present

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