Steven M. Bidstrup, P.E.

** ******** ****, *******, *** Hampshire 03755

315-***-**** | abgf57@r.postjobfree.com

Summary

Experienced engineering manager with a strong background in leading matrix

engineering teams and managing small and large capital projects in a cGMP

environment. Roles held include Manager of a Facility Engineering Group

and Associate Director in a Corporate Engineering Group for a global

biopharmaceutical company.

Experience

OLYMPUS BIOTECH CORPORATION, Lebanon, NH 2011-2012

Manager, Facilities Engineering Department

. Managed the Facilities Engineering Department consisting of four

project managers, two building automation engineers, and one CAD

professional.

. Executed the site's capital plan for facilities projects focused on

improving reliability, energy savings, and productivity in a GMP

environment. Small projects managed included an autoclave

refurbishment, cold room installations, glass washer cycle

modifications, aseptic isolator fabrication and installation,

conceptual designs and estimates for facility modifications to support

multiproduct manufacturing and infrastructure projects.

. Maintained building automation systems and SOPs.

. Supported authority inspections, deviation investigations, and CAPAs.

. Improved HVAC operations resulting in a 25% reduction in energy use,

and optimized capital project scope and executions strategies

resulting in $1.5 MM in capital savings.

FMC CORPORATION, Tonawanda, NY 2010-2011

Manager, Technical Services Engineering Department

. Directed the application engineering group consisting of four

engineers, five mechanics and two product support specialists with

responsibility for the engineering and installation of specialty

chemical storage, distribution and application systems at customer's

sites, and development of new applications for FMC products.

. Applied and developed technologies include those for aseptic juice,

contact lens solution formulation, food disinfection, paper bleaching,

water treatment, and flue gas treatment. Conducted hazard analyses on

new applications.

. Represented FMC as the principle technical contact for customer

inquiries regarding new and existing applications.

BRISTOL-MYERS SQUIBB COMPANY, Syracuse, NY 1990-2010

Associate Director, Engineering (2004-2010); Project Manager, Engineering

(2001-2004);

Managed internal project managers and outside consultants engaged in the

design, construction and qualification of high impact projects for the

production and development of biologics by mammalian cell culture. SME

for regulatory inspections. Engineering consultant within the Company's

global operations. Responsibilities included:

|Scope and Process Definition |Town Board Presentations and Permitting |

|Cost Estimation |Construction Management and Safety |

|PFD/PID creation |Contract Administration |

|Facility Layouts |Cash Flow Management |

|Detailed/Value Engineering |Equipment Purchase and FAT |

|Building Code Review |Commissioning/Qualification of GMP Equipment |

Project start-up included the shakedown of the equipment and utilities, and

establishment of initial maintenance procedures. Many of these projects

were completed under an accelerated time table, with careful planning to

minimize production down time.

High Impact Projects Managed:

. Specification, purchase, and fabrication of the process and utility

equipment for the Devens Massachusette's Large Scale Biologics

Facility including cell culture skids, a centrifugation skid, an ultra-

filtration skid, chromatographic separation skids and columns, super

skids for buffer/media preparation and hold, clean steam generators,

high purity water generators, media handling equipment, and utility

equipment such as boilers, chillers and compressors. Established a

quality plan for third party inspection personnel to insure the

equipment was fabricated in accordance with ASME biologics process

equipment requirements and equipment specifications. Coordinated

factory acceptance testing and equipment turnover package

documentation. Equipment Cost: $92 MM.

. A 40,000 ft2 expansion of an operating Biologics Pilot Facility

including Class 100,000 through Class 100 clean rooms, high purity

water generation/distribution, chromatography purification suites,

buffer preparation and process support areas, HVAC systems,

laboratories and general office areas. Included qualification of

process and clean utility equipment. Cost: $40 MM.

. Renovation of 50,000 ft2 in two existing building complexes to create

new process development and analytical laboratories for biologics

along with associated office space. Included significant utility

enhancements to support the increased HVAC and USP water requirements,

and new laboratory analytical equipment. Cost: $32 MM.

. A facility renovation of biologics process operating areas and

utilities to convert a biotechnology pilot plant into a FDA approvable

commercial manufacturing facility. This project included extensive

facility enhancements, modifications to mammalian cell culture

reactors and media prep vessels, as well as re-qualification of all

production equipment, associated clean utilities and infrastructure.

Cost: $22 MM.

. The design and implementation of a new facility and an interim

facility for the freezing, storage, thawing, and shipping of a

biologics intermediate. Cost: $13.7 MM.

. Installation of centrifugation and filtration capabilities for cell

culture harvest operations. Included modifications to high purity

piping to allow for concurrent manufacturing of two products as well

as modifications to building architecture, HVAC, clean utilities, and

process control systems. All construction occurred in a clean room

environment in close proximity to active manufacturing operations.

Cost: $11.7 MM.

. Expansion of clean (WFI/RO) water generation and process equipment

clean-in-place capacity and piping for an operating biotechnology

facility. Cost: $5.2 MM.

. Renovation of an existing cell banking area to meet an EU request for

a sterile area. Included programming, architectural and HVAC

modifications, and qualification.

. Designed concept to develop the scope and definitive cost estimate for

the demolition of 53 production and support buildings, reconfiguration

of centralized utilities, and restoration of site landscaping. Cost:

$60 -70 MM.

. Emergency power generation system to provide back-up power. Cost:

$2.7 MM.

. Renovation of a manufacturing area for the fermentation of Taxol.

. Small project capital portfolio of 20 to 30 infrastructure, process,

and laboratory projects with an annual budget of $4M dollars.

BRISTOL-MYERS SQUIBB COMPANY, - Experience Continued:

Facility Manager, Pretreatment Plant Operations (1995-2001); Environmental

Engineer (1990-1995)

. Advised corporate engineering and site management on the design and

construction of a $35 MM biological wastewater pretreatment plant.

. Managed the start-up, operation, maintenance, safety, and budgetary

control of the plant with a $3M annual operating budget and an

operating staff of 11.

. Implemented a $4.5 MM project to improve the performance of the

treatment system that included the installation of major

electrical/mechanical equipment, instrumentation, chemical

distribution, odor control, tanks, and building construction.

. Interpreted and applied environmental regulations, reviewed capital

projects for environmental impacts, and interfaced with regulatory

officials.

. Conducted employee environmental training and audits, manifested and

tracked the disposition of bulk hazardous waste and laboratory

hazardous waste, maintained compliance with bulk storage requirements,

and managed consultant services.

. Prepared SPDES, Corp. of Engineers, air, chemical bulk storage and

fuel storage permit applications, and submitted SPDES and County self-

monitoring reports. Participated in process hazard analyses.

. Installed, operated, and maintained three pilot industrial wastewater

treatment systems and a full scale ground water treatment system.

Removed and closed underground tanks.

. Managed a site-wide assessment of impacts to the groundwater and soils

on the site.

. Emergency response team coordinator.

SIRRINE ENVIRONMENTAL CONSULTANTS, Greenville, SC 1987-1990

Project/Environmental Engineer

. Completed the conceptual process and detailed design of three

wastewater treatment plants, and two treatment plant upgrades.

. Developed cost estimates, engineering specifications, process and

instrumentation diagrams, and general arrangements.

. Evaluated and determined optimum treatment technologies for

groundwater and industrial wastewater including biological treatment,

activated carbon adsorption, filtration, chemical precipitation, and

ion exchange.

. Negotiated treatment limits with regulatory officials, preparing spill

response plans, obtained air, water, and RECRA Part B permits.

Education

Master of Science, Environmental Engineering, Clemson University, Clemson,

SC

Bachelor of Science, Chemical Engineering, University of Wisconsin,

Madison, WI

Certification

Licensed Professional Engineer, State of New York

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