Curriculum Vitae

For

Bret A. Fisk, P.E.

Consulting Expertise Summary: Bret A. Fisk, P.E. (LTC – Automation & Control Engineering) has been a significant contributor to automation strategic initiatives since joining the company as a M.S. Electrical Engineering graduate of the University of Michigan in 1981. His worldwide design consulting assignments include the new Humalog production site in Puerto Rico; the U.S. Xigris production facility; the Fegersheim Humulin cartridge filling facility; the U.S. Humulin production facilities; the Speke BST production facility; the Kinsale Fluoxetine production facility; the U.S. Capsule Operations automation project; and four U.S. fermentation pilot plant projects. Bret also led the development of the Rockwell Automation Alliance; process instrumentation strategic sourcing and standardization; the development of automation knowledge management; and the development/application of Smart Plant Instrumentation. He has been an active member of JETT, ISPE and ISA. Currently, Bret is a QA consultant for Lilly manufacturing facilities in Indianapolis.

Bret combines his automation technical expertise, team leadership skills, and general business understanding to significantly effect the automation discipline direction across the corporation. Bret has a very good relationship with his peers in and outside the company. He is leading industry with his innovative efforts with: Process Instrumentation Strategic Sourcing and Standardization; the JETT Consortium; and the application of Smart Plant Instrumentation. Bret is a good fit for positions in which a strong technical background is needed in combination with the ability to manage for results.

Affiliations and Societies:

Organization

Membership Dates

Good Automated Manufacturing Practice (GAMP), Joint Equipment transition Team (JETT) Special Interest Group

ISPE – International Society of Pharmaceutical Engineers

ISA – Instrumentation, Systems, and Automation Society

1999 to present

1999 to 2008

1981 to present

Qualifications and Experience:

Education:

School

Degree/Certification

Dates Completed

State of Indiana

University of Michigan

Hope College, Holland Michigan

Professional Engineering License

M.S. / Electrical Engineering

B.A. / Engineering Science

1986

1981

1980

Work Experience:

Employer

Role / Responsibilities

Dates Employed

Eli Lilly & Company, Technology Center

Eli Lilly & Company, Corporate Center

Eli Lilly & Company, Corporate Center

Eli Lilly & Company, Corporate Center

Eli Lilly & Company, Corporate Center

Eli Lilly & Company, Corporate Center

Eli Lilly & Company, Technology Center

Eli Lilly & Company, Technology Center

Eli Lilly & Company, Affiliate

Eli Lilly & Company, Affiliate

Eli Lilly & Company, Technology Center

Eli Lilly & Company, Affiliate

Eli Lilly & Company, Technology Center

Eli Lilly & Company, Technology Center

Eli Lilly & Company, Technology Center

Eli Lilly & Company, Technology Center

Consultant Engineer, USA,

Quality Assurance

Consultant Engineer, USA,

Global Automation & Control Engineering

Associate Engineering Consultant, USA, Global Automation & Control Engineering

Associate Engineering Consultant, USA, Global Process Control Engineering

Associate Engineering Consultant, USA, Global Automation Delivery

Associate Engineering Consultant, USA, Global Facilities Delivery

Sr. Process Control Engineer, USA, Information Technology Y2K Program

Sr. Process Control Engineer, USA, Technology Center

Sr. Process Control Engineer, FR, Fegersheim, Humulin Cartridge Facility Project Team

Sr. Process Control Engineer, FR, Paris, BHI Production Facility Project Team

Sr. Process Control Engineer, USA, BHI Production Facility Project Team

Project Engineer, UK, Speke, Dista BST Project Team

Project Engineer, USA, Dista BST Project Team

Project Engineer, USA, Capsule Machine Automation Project

Project Engineer, Ireland, Kinsale, Prozac Production Facility Project Team

Project Engineer, USA, 3 Fermentation Pilot Plant Automation Projects, Corporate

2012

2009

2007

2004

2002

1999

1998

1994

1992

1991

1989

1988

1987

1986

1985

1981

Consulting Projects:

Project

Dates

Project STAR

Rockwell Alliance

Process Instrumentation Integrated Sourcing Agreement

Process Instrumentation Standards

Automation WELL

JETT Consortium

Global Facilities Delivery C4I Design Gate Review Process

Automation Lead for PM30 in Mayaguez

Life Cycle Asset Management System

BHI Emergency Action System Remediation

IC Utilities PLC Upgrade Project

Sustainability and Electrification

1994 - 1998

1994 – 1998

1994 – 1998

1997 – 2000

1999 – 2009

2001 – 2002

2002 – 2003

2002 – 2009

2009 – 2010

2010 – 2011

2012 – 2015

Established Rockwell Automation Alliance (considered to be Lilly’s most successful automation alliance)

Led U.S. Team in selecting and starting up our integrated sourcing agreement with Process Automation Sourcing Solutions, consolidating over 150 supply channels, reduces procurement process by 50%, and provides a channel to control stds.

Led U.S. Team in establishing process instrumentation standards for the corporation which are rapidly becoming global stds.

Led the Automation Discipline’s migration to the WELL (for the management of technical discussion & knowledge). Recruited, trained, & mentored section leaders on the use of the WELL.

Membership Chair, Financial Chair, and scheduler for JETT (GAMP Special Interest Group focused on improving industry validation practices for package systems). Let recruiting for the team which has grown from 6 to over 50 companies in 2 years. JETT is now internationally sponsored by ISPE & GAMP (http://www.ispe.org/jett).

Co-Led Team in Developing C4I business process for managing design development for major capital projects ($10 to $500M). Process has been institutionalized by the whole division and is being applied to all projects.

Developed the vision for the Automation Strategy & Staffing Plan for PM30, a new chemical manufacturing facility for Atomoxetine (Stratera). Led the PM30 Automation project team.

Drove the vision and the development of Lilly’s new Life Cycle Asset Management System. This implementation is leading the industry in integrating and validating several isolated I.T. business processes associated with managing manufacturing assets.

Drove the creation of BHI Emergency Action System Loop drawings utilizing Smart Plant Instrumentation (SPI). Trained additional users on SPI in the process.

Led the SPI loop drawing design for a site utilities PLC platform upgrade. Trained new SPI users on the project through design workshops.

Led the development of multiple Sustainability and Electrification Proposals for the Lilly Facilities, Sales Fleet, and Shuttle service.

Accomplishments: (Publications, presentations, and patents)

Leadership Activities:

GMP Engineering and Maintenance Site Quality Plan Ownership/Management

Measurement Uncertainty Subject Matter Expert

Lilly Asset Management System & Smart Plant Inst. Configuration & Training dev., Instructing, and consulting (positive feedback on over 24 tech. demos, presentations, & training sessions)

“SPI Inst. Spec. Library” (73 BIO-Pharma Ind. Std. Spec. Forms) – led tech. dev. collaborating with Lilly internal experts and four delivery partners.

Led Computer System Validation, GAMP/JETT, and COD/MU Training for GFD Division

Co-Led GFD C4I Design Mapping Team with Bruce Beck

GAMP/JETT training and presentations (“How to Apply CSV to Packaged Equipment”) for: Fluor; Jacobs; Advanced Technology Group; Equipment Development; Global Facilities Delivery; Interphex workshops; ISPE regional and national meeting workshops; supplier presentations/workshops; Auto. Leadership Council; PAINT Tech. Council; QA/QC Staff groups.

Knowledge Exchange: Worldwide Eli Lilly Learning (WELL) and eTEAM: Utilization/Promotion/Development:

-Led automation discipline migration to the WELL

- Promotion/networking multi-discipline and delivery partner usage

-Technical expert for Process Automation, Process Instrumentation, Rockwell Automation, providing automation consulting services across the corporation (technical expert for 13 sections, and subscribe to over 90 sections)

-Set up eTEAM for our department to manage staff meetings, design mapping C4I team, Planning C4I team, Validation and Commissioning C4I team. This was the seed for further eTEAM usage across the division.

Trainer/Mentor for Engineering Vax Inventory, Specification, and Lilly Diagram Information System (LDIS) databases – for Lilly and our A&E delivery partners

External Associations:

Smart Plant Instrumentation Local Technical Users Forum (SPI LTUF)

Joint Equipment Transition Team Consortium (JETT) – ISPE/GAMP Special Interest Group

-Membership/Recruiting Chairman; Schedule Chairman; Financial Benefits Chairman

Indiana Basketball Association (IBA) – Youth Basketball Coach

GAMP America Steering Committee

International Society of Pharmaceutical Engineers (ISPE)

Benchmark Lilly automation practices with industry practices

CastleView Baptist Christian Church (men’s basketball; young married couples class; couples small group; men’s accountability group; youth basketball and baseball coaching)

East 91 Street Christian Church (small support group leader; chaired sports ministry team; “Growing Kids God’s Way” group member; “Experiencing God” Study; Nursery)

Instrument Society of America (ISA)

Publications:

An Implementation of ISA20 (Specification forms for Process Measurement & Control) – brokered contract via extensive networking with 7 companies and 3 legal departments.

Lilly Technical Reports:

Automation and Life Cycle Support Strategies (Co-authors: P. Owen, J. Lauterbach)

Computer Controlled Pkg Sys Acquisition (Co-authors: P. Owen, J. Lauterbach, J. Kiely, D. Schrader)

The Make / Buy Decision – Internal and External Perspectives (Co-authors: R. Gunyon)

Instrumentation and Controls FAT Summary and Checklist (Co-authors: B. Nickelman)

Lilly Engineering Drawing Standard (Development team member)

Instrument Data Sheets MS16922

Dry Loop Check Forms & Procedures (institutionalized in LAMS & BO reports, and FEPI).

Control Panel ETG 15981 – brokered rev. collaborating with internal tech. exp. & 4 GFD partners

PLC Technology Positioning Chart (PLC hardware and software standards)

Co-authored, networked internally, and provided content input for numerous JETT Publications

(all documents available on http://www.ispe.org/jett)

-“Let’s Talk about Equipment Validation,” Pharma and Medical Packaging News

-“The Engineer’s Dilemma,” Journal of Validation Technology

-GAMP4 Best Practices User Requirement Specification Templates (24), available for industry use on www.jettconsortium.com

Validation of Process Control Systems – Key contributor to this joint GAMP Publication between JETT and the GAMP Process Control Special Interest Group in the U.K.

Date:

2012 – Present

2011 – 2012

2001 – 2012

2003 – 2012

2002 – 2005

2001 – 2003

1999 – 2012

1999 – 2010

2001

1984 – 2010

2006 – 2012

1999 – 2012

2006 – 07

2002

Member 99 – 2008

Member 01 – 2007

Member 82 – 2001

Member 82 – Pres

2007 – 08

2005 – 08

2005 – 08

2007 – 08

2007 – 08

2006 – 07

2006 – 08

2004 – 08

2002

1999

2001

2001

2002

2003

Accomplishments: (continued):

Team Activities:

Lilly Indianapolis Facilities Health, Safety, and Environmental Council Team Member

Indianapolis Kings JH and JV Baseball Coach (http://www.indykingsbaseball.org/)

East Side Eagles Basketball JH and JV Assistant Coach (http://indygoldeneagles.org/)

Chartered 3 Six-Sigma efforts, “Controlled Pkg Sys Acq.”; “Maintaining Initial Conditions”; & Operations Information Retention for I&C

ETC Recognition Team – Key Role in creating new benchmark for ETC Annual Recognition

Engineering Functional Drawing Standard Team Member – EFS-3005 “Engineering Drawings”

Engineering Asset Data Manual (Instrument and Controls Technical team member)

Life-Cycle Asset Management System (LAMS) Project Team Lead User Representative

Smart Plant Instrumentation Application Specialist

Rockwell Alliance Auditing Team

-MDT PLC Change Mgmt. Software Global Purchasing Agreement (~150K savings)

-Rockwell Global Engineering Services Agreement (est. $30M savings over 3 yrs.)

-CSQ, B105, B100, and Pharmacia joint CSV audit

Mater Specification and Engineering Technical Guideline Change Control Board

World Wide Eli Lilly Learning (WELL) Change Control Board Member

Corporate Process Instrumentation Standards Team

Lilly Softball League (Co-Captain and League Champs 2003-2005; 2003 MVP)

Date:

2012 – Present

2009 – 2012

2008 – 2012

2007 – 2009

2007

2006 – 2007

2002 – Present

2001 – 2008

2001 – Present

1999 – 2004

2001 – 2003

1998 – 2003

1995 – 2004

1981 – 2007

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