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