Steven F. Szabo, P.E.

_____________________________________________________
Conscientious, energetic and hard-working Mechanical Engineer with over 23 year
s experience in the pharmaceutical industry with a proven track record of succes
s in the management of capital projects from inception through completion. Consi
stently delivering within budget, schedule and quality expectations. Strong inte
rpersonal, communication and leadership skills and highly respected among peers
and colleagues in this industry. Very knowledgeable in the FDA, cGMP guidelines.
Able to aggressively take on new challenges and constantly eager to acquire add
itional knowledge and skills through study and experience.

PROFESSIONAL EXPERIENCE

IPS (Integrated Project Services)

4/2010 - Present
Lafayette Hill, PA
Project Manager
Assigned to perform project management, commissioning support, and preventative
maintenance related services for Ben Venue Laboratories, Bedford, Ohio; Manufac
turing Science and Technology Pilot Plant Facility.
Provide on-site project management to lead and complete commissioning activitie
s of a newly built Pilot Plant which will serve to address product remediation,
scale-up, technology transfer, and new technology development.
Pilot Plant capabilities include weighing and compounding operations, lyophiliz
ation; filling, capping and packaging; and equipment cleaning. Scope of project
includes utilities; DI water, WFI, plant steam, industrial grade compressed air,
nitrogen, HVAC, cooling tower water, electrical power and back-up power.
Isogen LLC, Advanced Sterile Processing
12/2008 12/2009
Newark, DE
Director of Engineering
Principal Engineer, Facilities & Process
Oversee all engineering functions of a startup company which provides advanced
sterile manufacturing of potent and non-potent therapeutics for the critical cli
nical / commercial scale manufacturing transition. This site has a fully integra
ted suite of services including formulation, tech transfer and validation servic
es for the contract filling of liquids and lyophilized formulations for vaccines
, mAbs, and other synthetic and biologically derived therapeutics.
Responsible for the Engineering Department which encompasses Engineering Servic
es, Capital Projects, Process Architecture, Environmental & Safety, Industrial H
ygiene, Maintenance and Metrology.
Principal Engineer responsible for the construction of the facility, validation
and startup of all equipment, facility & process systems installed in the site
Science Center, also establishing the Preventative Maintenance, Calibration and
Safety programs.
Responsible for daily operations of all critical systems including CS, WFI, Pro
cess Air, HVAC and electrical systems.
Report on the status of equipment, utility and facility engineering projects.
Participate on the Quality Review Board.
Plan resource utilization for project execution.
Prepare and implement department goals, objectives, budget and cash flow plans.
Prepare and maintain equipment & utility systems (all equipment, utilities. HVA
C and electrical) documentation (Drawings, URS, FS, SDS, TRMs, RA, etc).
 Ensure that the facility, equipment and utilities are operating in compliance,
in conjunction with validation & manufacturing.
Provide technical mentorship to staff, including mechanical and chemical proces
s engineers and technicians.
Schering-Plough, Kenilworth, NJ
3/2003 12/2008
Manager, Engineering Projects
NJ Operations Engineering
Manager of the Project Engineering Department consisting of a team of (28) per
manent/fulltime employees; including staff level Project Engineers & Project Man
agers (Mechanical, Chemical and Electrical), Validation Engineers, Facilities En
gineer, CAD Technician, machine shop, Shop Supervisor and (3) Machinists plus cl
erical assistance to ensure projects are kept on schedule and within budget. Als
o manage additional contract engineering support per workload requirements. Lead
all plant-wide engineering capital project activities for Solid Dosage, Liquids
, Creams and Ointments, Aerosols, and Medical Device manufacturing and packaging
of products including Lab and Infrastructure projects.
Responsible for scope development, programming and review, design and review,
internal project communication with upper management and interfaces with clients
, procurement of equipment and external resources, installation, start-up and al
l qualification activities.
Responsible for all project activities from specification of equipment or facil
ity, FAT, SAT, installation, ES, COM, IQ/OQ and PQ.
Manage and prepare for approval annual capital plan in excess of $50 million pl
us departmental budgets. Work closely with Project Managers and assigned enginee
ring support in design, financial approval, installation and construction, quali
fication, review and approval of master drawings for the entire site and project
close-out packages.
Worked closely with Site Leadership Team over the past five years to complete a
Site Validation Master Plan to successfully lift a Consent Decree with the FDA.
Involved with many FDA inspections during the Consent Decree acting as a techni
cal advisor.
Pfizer, Morris Plains, NJ
2001 3/2003
Senior Research Associate, Packaging Design & Development
Global R&D, Packaging Pilot Plant
Provided equipment engineering and project management expertise in the commerci
alization of new products globally. Lead cross-functional teams in the developme
nt of new package concepts and implemented efficient, cost effective packaging p
rocesses.
Responsible for tech transfer of packaging equipment & package development know
ledge from pilot plant to operations. Managed equipment installations globally,
supervised local engineering support as required.
Responsible for generating specifications, prototypes, cost estimates, schedule
s and presentations to management.
Responsible for the launch of several new products packaged in blisters, pouche
s, bottles and vials. Main technical resource within R&D for equipment evaluati
on and selection, helped develop (3) patentable technologies.
Leader of Global Packaging Core Team in driving innovation into new packaging d
esign, developed strategic vision and goals, and chartered interdisciplinary tea
ms for change management.
Directly supervised (7) Packaging Engineers, (3) Pilot Plant Technicians and CA
D draftsman.
Received Pfizer Accomplishment, Creativity and Innovation and Presidents Achiev
ement Awards.
Wyeth-Ayerst Pharmaceuticals, Marietta, PA 1
998 2000
Wyeth-Lederle Vaccines and Pediatrics
Project Manager
Managed selection and installation of new vial filling line for new product lau
nch of RotaShield Rotavirus vaccine. Filling line integrated to three Lyophilize
rs including fully automated vial transport system for shelf feeding and unloadi
ng as well as 100% in-line inspection. Total project approved at $25 million inc
luding new building annex, personally responsible for $14 million of this projec
t.
Bayer Corporation, Myerstown, PA 1990
- 1998
Consumer Care Division
Senior Project Engineer (1992-1998)
Oversaw all capital project activity for both manufacturing and packaging of So
lid Dosage OTC and Rx products at the Myerstown facility. Managed and participat
ed on project and divisional strategy teams for all current and new products. Po
sition supported North American operations, U.S., Canada, Mexico and Central Ame
rica. Controlled ongoing capital projects in liquid side of business during rest
ructuring of technical support departments for an 8-month period.
Managed equipment installations for Aspirin production in Canada, relocated Ale
ve packaging through joint venture agreement from Puerto Rico to U.S. Participat
ed on core team in developing consolidation plans of Elkhart, Indiana plant tran
sferring Alka-Seltzer production from Elkhart to Lerma, Mexico and all Vitamin p
roduction to Myerstown, PA. Supported startup efforts and tech transfer of table
t printing operations in newly built facility in Bittlefeld, Germany.
Managed all engineering project activity in the expansion of the SD Manufacturi
ng area including blending, compacting, compression, coating and tablet printing
operations. Installation and startup of both single & double-sided rotary table
t presses, experience with Manesty, Stokes, Fette, IMA, Korsch and Courtoy. Expe
rience in compressed tablets and multiple compressed tablets.
Responsible for projects associated with the transfer of products from other si
tes and startup of sugar-coated tablets, film, enteric and gelatin-coating opera
tions.
Responsible for projects in wet & dry granulation as well as direct compression
. Installation and startup of Niro and Glatt fluid bed granulation processes.
Project Manager of following projects from inception through completion:
o Uhlmann Blister lines, 600 per minute through traypacking, casepacking and rob
otic palletizing. This project required custom designed equipment & methods for
feeding and cold storage of very challenging Alka-Seltzer Cough/Cold Liqui-Gel p
roducts. Lines were designed to be premier showcase lines within Bayer, AG.
o High-speed Siebler Pouch Packaging Line for Bayer Aspirin, Midol and Aleve pro
ducts.
o Involved in design and startup of state-of-the-art Gel Coating process, first
for Bayer Corp.
Managed packaging efficiency upgrade and safety related projects in SD packagin
g areas.
Received four company Vision and Accomplishment Awards.
Senior Mechanical Engineer/Supervisor (1990-1992)
Managed capital projects totaling $8MM annually, supporting Solid Dosage Produc
ts business of the plant.
Directed a company effort in conjunction with a major US packaging equipment su
pplier in designing and developing a new generation cartoning machine. Project s
uccessfully achieved several approved patents.
Held responsibility of packaging improvement plan. Led team towards a 45% incre
ase in productivity of eight high-speed bottling lines within 22 months of start
.
Responsible for all maintenance activities including PMs, calibrations, trouble
shooting and spare parts inventory in support of a 3-shift Solid Dosage Packagin
g operation.
Johnson & Johnson Corporation. Milltown, NJ
J&J McNeil / PPC
Positions held: Development Design Engineer (1989-1990)
Technical Advisor/Maintenance (1988-1989)
Equipment Engineer (1986-1988)
Responsibilities included: Directing installations of high-speed production line
s, associated packaging and central accumulation systems, controlling project bu
dgets and schedules. Interfaced closely with central design and developmental en
gineering groups.
o Supervised staff of 25+ maintenance personnel (mechanics, electricians and mac
hinists) and two draftsmen. Responsible for troubleshooting, PMs, calibrations a
nd spare parts inventory in support of a 3-shift manufacturing operation.
o Responsible for process development of new products and line extensions, liais
on between R&D and production.

Education & Training

BS, Mechanical Engineering, Drexel University, Philadelphia, PA - 1986
Professional Engineer in Pennsylvania
Continuing Professional Development
Six Sigma and RFT Training - 2008
Management Excellence Training - 2008
Design of Oral-Solid Manufacturing Facilities with HVAC Emphasis ISPE - 2005
FMEA (Failure Mode and Effects Analysis) / Six Sigma Rath & Strong - 2004
University of OPP, Mobil Chemical Films - 2003
Flexible Packaging Technology, Pechiney Plastic Packaging Inc. - 2002
MIT Industrial Liaison Program Research Applicable to Packaging - 2002
New Developments in Consumer Packaging - Clemson University - 2001
Achieving Quick Changeover / SMED System - 2001

Professional Association
Institute of Packaging Professionals, ASME, ISPE, National Society of Profession
al Engineers, American Mensa Ltd.
Completed Graduate Certificate Program in Pharmaceutical Manufacturing Practices
at Stevens University - 12/2006.
Currently pursuing Masters of Engineering Degree in Pharmaceutical Engineering w
ith emphasis in Bioprocess Technology & Aseptic Facility Design, expected comple
tion Fall 2010.
Member of Tau Beta Pi Honor Society.