Mechanical Engineer

**** *** ***** **. #****, Pasadena, Texas *****, 512-***-****, *******.****@*****.***

Mona R. Holman

Expertise Quality (engineering, assurance and control), facility maintenance and management, audit and

compliance, production/manufacturing supervision, preventive and corrective action, and safety

Education MBA – St. Edward’s University, Austin, Texas (2004)

BSME (Bachelors of Science in Mechanical Engineering) – Prairie View A&M University,

Prairie View, Texas (1993)

Knowledge & Skills GMP (Good Manufacturing Practices), CAPA (Corrective Action Preventative Action), FDA and other regulatory requirements, manufacturing/production processes and procedures, maintenance and preventive maintenance, product and project safety, NDA (New Drug Application), HACCP, 21 CFR Parts 210 & 211, SIX SIGMA GREEN BELT CERTIFIED

Work History

12/07 to 4/11 Jacobs Engineering Technology (NASA-Johnson Space Center, Houston, Texas)

Quality Engineer III-Facility Engineer

Provide quality engineering support and guidance to the astronaut space station training facility, vibration and acoustic, and Arc Jet testing facilities. This support and guidance include being responsible for the following: requirement review and development, concept review, design review and approval, product development, process adherence, unit testing, regression/integration testing, and end-to-end testing. Act as quality liaison between the customer (NASA) and the supplier (Jacobs’ and its partners). Interface with Engineering and Operations to ensure transfer to production of new products are in accordance with approved data. Attend and support test readiness reviews, preliminary and critical design reviews to provide technical input for inclusion into requirements’ documentation during the design phase of products/hardware. Ensure product functionality complies with system specifications and maintains high degree of compliance with business and process documentation. Interface with cross functional teams to ensure issues are addressed quickly and with quality results.

Accomplishments

Recognized by NASA with an award for ability to work well others, maintain an open line of communication between project and quality engineer, and catching the important errors in the paperwork. All this was done so that an important task could be performed on the ISS, International Space Station, the next day.

03/01 – 11/07 HOSPIRA, INC. (Formerly Abbott Laboratories), (Austin, Texas)

Sr. Manufacturing Quality Supervisor (Final Release of Product/Batch Record Release)

Managed the facility’s product (intravenous bags) release department by reviewing and approving manufacturing batch records; made decisions on the disposition of products and occurrence of any deviations during the manufacturing process. Supervised 8 batch record auditors; the audit ensured accuracy of information recorded and for compliance to cGMP’s and standard operating procedures, and testing of the products. Coordinated and developed product delivery schedules. Prepared and executed batch records for process validations, stability and R&D runs; wrote, revised, reviewed and approved specifications and procedures. Led and participated in capital projects for the continuous improvement.

Accomplishments

- Lean Manufacturing-yield a $2.1M/year cost avoidance by optimizing the days of product released.

- Involved in 4 FDA new product submissions; plant liaison with corporate office.

- Installed computer system to verify the receipt of batch records; decrease likeliness for product

destruction (savings, $50K to over $500K). Lean Kaizen approach used to reduce batch record delivery

time to Quality for product release; from 72 to 24 hours.

- Through the use of Value Stream Mapping and 5S’s, eliminated non-value added auditing processes.

- Initiated a project using the Six Sigma methodology to reduce the number of errors in batch records.

08/98 – 03/01 ABBOTT LABORATORIES, Manufacturing Quality Supervisor and production supervisor

08/97 – 08/98 VLASIC FOODS INTERNATIONAL (Imlay City, Michigan), Process Engineer/Team Manager

11/96 – 08/97 NABISCO MILKBONE BAKERY (Buffalo, New York), Production Shift Leader

11/94- 11/96 GENERAL MOTORS (Dayton, Ohio), Production/Maintenance Supervisor, Manufacturing Project Engineer

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