Project Manager Engineering

William Michael Jackson

*** ** *** ******

Evansville, IN 47713

812-***-**** (home) 812-***-**** (cell)

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

Qualification Summary

* Extensive experience in Rx, OTC, and generic pharmaceutical (liquids, creams, ointments, solids), and food and beverage manufacturing facilities, including starting up new and renovated facilities

* Technical management of manufacturing facilities including production/facility engineering and maintenance (preventive, predictive and corrective), capital investment development and implementation, cGMP compliance (IQ/OQ/PQ, change control, and documentation)

* Management and development of technical and non-technical staffs with up to 12 direct reports and 120 indirect reports.

* Lean, Six Sigma, 5S, and Operational Excellence Kaizen experience in a manufacturing environment

* Extensive experience interfacing with external equipment vendors and contractors, and outside agencies (local permitting agencies, FDA, OSHA, etc.)

* Project management of capital investment projects for packaging/processing equipment, including justification, design, procurement, installation, and start-up for projects up to $25 million

* Thorough working knowledge of FDA regulations (CFRs) for implementing cGMPs. Experience with FDA and EU audits at pharmaceutical sites.

* Implement environmental, health and safety policies according to company and government guidelines (OSHA, EPA, NYDEC, etc.)

* Experience with Master Planning development, and long term strategic capital planning

* Cross-functional team leadership experience with excellent organizational skills

* Contributing author to ISPE Good Practice Guide on Maintenance

Work Experience

Mead Johnson Nutrition, Evansville, IN. May 2011 to Present

Engineering Manager. Responsible for engineering and automation groups for capital investment projects for the Evansville Supply Center (ESC). Member of ESC Leadership Team. Significant accomplishments include:

* Project Engineering Lead for 6 oz plastic bottle packaging project - $6MM

* Supply Chain Engineering lead on cross-functional team for developing long term strategy for a new

aseptic processing and packaging line, and conversion of existing can line to plastic - $40MM

investment planned starting in 2014.

* Project Engineering lead for project to launch Infant Formula in 8 oz plastic bottles - $2MM

* Team leader of Mead Johnson North America Supply Chain Sustainability team

* Team leader for ESC Inclusion and Diversity team

* Led development of ESC Engineering guidelines for procurement of capital equipment (design specifications, FAT & IQ/OQ protocols, safety and cGMP reviews, etc.)

* Peer Group lead for Energy Conservation team for Tri-State Manufacturing Alliance (TSMA)

Stiefel, a GlaxoSmithKline Company, Oak Hill, NY. May 2006 to May 2011

Director of Manufacturing and Engineering, January 2009 to May 2011

Responsibilities increased to include managing the 3 shift production operation, along with engineering and maintenance - total department of 132 people and a budget > $20 million.

Director of Engineering, February 2008 to January 2009

Responsibilities increased to include managing the maintenance and metrology departments along with engineering - total department of 48 people and a budget of $12 million.

Engineering Manager, May 2006 to January 2008

Manage the project, automation, process, metrology, and packaging engineering groups (12 professionals) with total departmental budget of $1.2 million. Member of site senior management team. Significant accomplishments include:

Engineering:

* Responsible for annual capital budget of approximately $5-$7MM

* Manage projects for purchase and installation of two new high speed bottle packaging packaging lines that reduced the cost of goods by 45% - $4.5MM. Projects were on time and on budget

* Development of a long-term facility plan for increasing the manufacturing and packaging capacity at Stiefel’s Singapore facility - $6MM project

* Member of strategic corporate team to develop a process for transferring technology between sites and from R&D to manufacturing. Member of all new product launch teams for Oak Hill site

* Development of long-term strategic investment plan to further reduce cost of goods and streamline the manufacturing and packaging operations.

Manufacturing:

* Member of technical team to develop Strategic plan for converting facility from pharmaceutical manufacturing to Oral Care Centre of Excellence for North America for GSK

* Responsible for maintaining cGMP compliance within production environment, including change control, batch records, validation, calibration, and equipment maintenance.

* Technical management sponsor for four OE teams: energy reduction, improving OEE in packaging (35% to 60% improvement), reducing packaging line changeover times, and packaging operator skills improvement

* Improved manufacturing and packaging schedule attainment from 60% to >95% over a one year period, while reducing WIP by more than $2 million

* Developed process to simplify batch records to reduce number of deviations by 50%

* Implemented work standards and accountability boards to address production floor level issues

Bayer HealthCare, Myerstown, PA. April 1997 to April 2006

Engineering Manager. Responsible for all engineering, maintenance, automation, utilities. and metrology at Consumer Care facility with 500 employees. Manage department of 37 people with annual operating budget of $10 million. Manage all capital project work at site with spending level $120 million over eight years. Member of site senior management team. Significant accomplishments include:

* Project Manager for relocating and upgrading vitamin production (processing and packaging) from another Bayer facility - $5MM. Project delivered on-time and under budget

* Leader of facility design/master planning efforts for 90,000 square foot expansion project for a new manufacturing/packaging building. Member of technical steering committee for $40MM expansion.

* Manage engineering functions for design/installation of new liquid manufacturing and packaging line ($3MM), bottle packaging lines ($2MM), new tablet coating equipment ($1.5MM), and various infrastructure projects (chillers, USP purified water generation and distribution, utility distribution, waste water centrifuges, etc.).

* Responsible for all equipment commissioning and IQ/OQ protocol preparation and execution, equipment maintenance, change control and metrology programs.

CIMA Labs, Eden Prairie, MN. June 1994 to September 1996

Director, Engineering. Responsible for all technical aspects of start-up pharmaceutical manufacturing facility designed to produce fast-dissolving solid dosage tablets. Significant accomplishments include:

* Manage $25 million project to renovate an existing building and install, start-up, and validate new manufacturing, packaging and utilities equipment. Equipment included new powder mixing and processing center, new tablet presses, and primary and secondary packaging for blister cards. Project completed on time and on budget

Bayer HealthCare, Elkhart, IN. April 1991 to June 1994

Plant Engineering & Maintenance Manager. Responsible for technical aspects of facilities and equipment used for production of effervescent and tableting for Consumer Care Division. Managed union maintenance staff of 32, with annual budget of $4 million. Significant accomplishments include:

* Project manager for new Alka-Seltzer pouch filling system - $2MM

* Project leader to implement software for maintenance and calibration programs

* Member of project team for upgrading laboratory and vitamin manufacturing areas

Other Work experiences include over ten years in the food processing and beverage industries (Mid-America Potato Company, Anheuser-Busch Inc., William Underwood Co., Welch Foods, Inc.)

Education

BS Degree in Mechanical Engineering from University of California, Davis.

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