Manager of Validations

CHRISTOPHER R. GOSSETT

Crystal Lake, Illinois ● 815-***-**** ● **********@*****.***

SUMMARY

• Experienced validation manager with strong technical and administration skills

• Successful track record in establishment and management of site validation programs

• Extensive experience in biopharma, medical device and aerospace industries

PROFESSIONAL ACCOMPLISHMENTS

Validation and Project Management

• Managed the validation activity resulting from product and equipment transfer and integration, following a corporate acquisition

• Created site validation master plans for two medical device manufacturers

• Managed multiple product improvement projects, coordinating with both customers and suppliers, to reduce customer complaints and improve profitability

• Managed facility capital expansion and improvement projects, including ISO 8 (class 100,000) clean rooms, gowning rooms and airlocks, walk-in coolers, QC laboratory and offices

• Managed an interdepartmental team which reduced the cost of the targeted military program by over $500,000

• Directed the corporate program to achieve ISO9001 registration, served as management representative to the registrar

• Directed the development of several new medical devices and medical industrial products, including a product line developed by off-site resources

Product/Process Improvement

• Eliminated product design flaws which drove customer complaints, re-establishing customer

and sales force confidence, and preserving a $2M/yr product line

• Reduced product labor content through automation of manual processes, resulting in $250k annual savings

• Reduced the total manufacturing cost of a mature product line by16%.

• Resolved regulatory issues with local FDA office, successfully averting the threat of a warning letter

Organizational Development

• Reorganized and expanded the engineering department to achieve corporate goals related to new product development

• Implemented standard engineering department procedures to achieve design and documentation control

• Established and managed plans for mentoring and cross training of maintenance technicians to improve effectiveness and provide growth opportunities

• Established several quality data collection and trending systems to satisfy FDA, ISO, and corporate requirements

EXPERIENCE

BIOMERIEUX, INC, Lombard, IL 2003-2011

Manager of Industrialization and Facilities Engineering

Company manufactures microbiological growth media for the pharmaceutical and food industries.

• Reports to Director of Operations

• Responsible for leading a small group with the following duties: equipment and process validations; specification and procurement of new equipment and improvements to existing equipment; equipment calibration; new product development; sustaining engineering for existing products; equipment and facilities maintenance.

OHIO MEDICAL CORP. (formerly Squire-Cogswell), Gurnee, Illinois 1992-2003

Manager of Engineering and Product Assurance

Company manufactures medical air and vacuum systems, medical gas regulators and portable aspirator products.

• Reported to President

• Responsibilities included: new product development; sustaining engineering for current products; quality data systems development for vendor and manufacturing department performance, customer complaint tracking, and service/repair tracking; regulatory affairs management (FDA); ISO 9001 and UL compliance management; and internal audit management.

HAMILTON SUNDSTRAND (formerly Sundstrand), Rockford, Illinois 1985-1992

Senior Product Manufacturing Engineer (final position)

Company (manufactures actuation and electrical subsystems for military and commercial aircraft.

• Responsible for manufacturing cost analysis, control, and cost reduction for current production products, and for cost estimating on new products.

• Promoted to Group Supervisor position, supervising four employees.

ADDITIONAL EXPERIENCE

Designed products and in-house test equipment for a variety of aircraft subsystems, including cabin pressurization, flap actuation, fuel and coolant pumping, and anti-icing.

EDUCATION

Master of Science, Theoretical and Applied Mechanics

University of Illinois, Urbana, Illinois

Bachelor of Science, Mechanical Engineering,

Purdue University, West Lafayette, Indiana

CURRENT AFFILIATIONS

International Society for Pharmaceutical Engineering (ISPE), Great Lakes Chapter

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