Engineer Quality Assurance

Mark Barnwell, CPP

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**** ******* ******, ******** *******, MI 48125, Mobile 734-***-****,

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

SUMMARY

Highly motivated and results driven Validation Engineer with 8 years

demonstrated success in the Pharmaceutical, Beverage, and Consumer Goods

industries. Possess a significant engineering background in equipment R&D,

process improvement, cGMP environments and manufacturing operations. Core

competencies include:

Packaging Technology Vendor Relations Equipment/Process

Validation

Project Management Quality Assurance Technical Support

EXPERIENCE

Plastipak Packaging Inc., Plymouth, MI 2008 to Present

Validation Engineer

. Manage a cross functional team to develop and implement a

standardized global equipment validation program.

. Lead corporate validation efforts for North/South American and

European bottle manufacturing facilities.

. Develop and execute equipment/process validations for high speed

PET/HDPE Bottling lines.

. Coordinate all validation activities with project leader, vendors,

plant management and corporate quality.

. Coordinate with vendor and plant management to develop/oversee

comprehensive training programs, equipment start-ups, and preventative

maintenance for plant personnel.

. Establish project management methodologies, processes and practices

as related to equipment validation and vendor evaluation requirements.

Pfizer, Inc., Ann Arbor, MI 2004 to 2008

Validation/Packaging Engineer

. Performed and supervised process validations and qualifications for

all pharmaceutical packaging equipment and materials within department.

. Supported the successful R&D and integration of additional packaging

equipment and/or upgrades to production lines.

. Successfully implemented packaging lines into calibration and

maintenance cycles to ensure accurate, efficient packaging runs.

. Created and supervised the progress of standard operating procedures

and specifications for packaging equipment and processes.

. Member of cleaning validation team that monitored all cleaning

validation activities for packaging and manufacturing equipment.

. Handled all equipment related deviations, incidents, Planned

Temporary Changes and Corrective action/Preventative actions.

. Provided technical support for equipment, equipment changeovers,

adjustments, and repair work during packaging operations.

. Acted as packaging liaison for Corporate, EU Regulatory and cGMP

audits.

FedEx Express, Farmington Hills, MI 2002 to 2003

Service Engineer

. Provided engineering support for 6 metro Detroit stations aimed at

producing cost effective and efficient station practices.

. Performed studies associated with am/pm sort operations and staffing,

route efficiency, on-road planning, forecasting, productivity, service

and cost performance and assisted station management in implementing the

required changes.

. Conducted extensive Best Practice audits for stations throughout the

Midwest.

EDUCATION

Michigan State University, East Lansing, MI

2000 B.S., Packaging

LICENSES AND CERTIFICATIONS\

Certified Packaging Professional (CPP), Institute of Packaging

Professionals (IoPP), 2007

Certified Six Sigma Lean Sensei (CSSLS), Villanova University, 2008

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