www.ispe.

org/newjersey

Published by the ISPE New Jersey Chapter

Serving New Jersey, New York and Northeast Pennsylvania
Editor: Scott Hickok Email: hickokrs@middough.com NEWSLETTER
and Matt Ferrier Email: matthew.ferrier@cagents.com
Volume 14, No. 2
Information: Phone and Fax 1.908.325.034

IN THIS ISSUE “Cooling Contingency Planning: Preparing for

Cooling Contingency Planning.
. . Page 1
Catastrophic Failure”
A Message From the President. by: Ed Szott, CEM
. . Page 3 Account Executive, Comprehensive Solutions
Trane New Jersey, Parsippany, NJ 07054 • 973-434-2168 • ecszott@trane.com
Help Wanted - Process

B eing prepared for the unexpected is good business practice. Most businesses and manufacturers
Engineer . . . Page 5
have in-place contingency plans to help manage the consequences of such business interruptions
New Jersey Chapter as a power outage, fire, computer failure, or chemical spills.
– Upcoming Events for
2007. . . Page 6 For a corporation where a single production line might represent revenues of $1 million per day, a sudden,
catastrophic building system failure – especially a failure of the heating, ventilation and air conditioning
Welcome New
system represents nothing less than a major economic risk for the entity.
Members. . . Page 7

Upcoming ISPE International The Food and Drug Administration (FDA) guidelines require that pharmaceutical manufacturers
Events. . . Page 8 maintain – and electronically document and validate – precise environmental conditions throughout their
manufacturing, warehousing, and distribution facilities at all times – failure or no failure.
Board of Directors. . . Page 9
A well-crafted, up-to-date HVAC Contingency Plan can protect inventory, minimize downtime, promote
2006-2007 Chapter employee comfort and safety, and otherwise manage or reduce the safety, financial and other risks
Committees. . . Page 10 resulting from a major HVAC system failure.

February National Engineers What is a Cooling Contingency Plan?

Week at Jersey Gardens Mall
Event. . . Page 11
Career Doctor Don. . . Page 12
February Baxter BioPharma
Solutions Event . . . Page 13
A contingency plan is “a plan for responding to a system emergency. The plan includes performing
backups, preparing critical facilities that can be used to facilitate continuity of operations in the event of an
emergency, and recovering from a disaster.” This definition, taken from a HIPAA security and electronic
signature standards glossary of terms, speaks to the issues involved in information security in health care
information systems.

Adapting that definition to the previously mentioned issues involving pharmaceutical manufacturing and
building HVAC systems, produces a quick and accurate description of what a “Cooling Contingency
Plan” is all about; “a plan for responding to a HVAC system emergency. The plan includes reducing risk,

(Continued on page 2)
Cooling Contingency Planning (Continued from front cover)
adding or improving component redundancy, preparing facilities
for rapid deployment of temporary equipment suitable to sustain
critical operations in the event of an emergency, and recovering
from a disaster.”
Planning the Plan
Start with the consequences of a major HVAC outage and ask
the following questions: How dependent are manufacturing
operations, information systems and product storage on comfort
cooling or process chilled water? What effect would there be
on manufacturing (and office operations) if the cooling system
failed or needed to be shut down for unplanned service? What
would be the cost of not having cooling for a day, or week on
production or inventory? Quantify these costs.
In addition, ask: Which individuals understand the consequences
of a failure? Who thoroughly comprehends the interplay and
dependence between the facility’s critical production, storage
operations and the environmental system? Who has in-depth
expertise in and experience with the details of the facility’s
HVAC systems – and the available alternatives?
The answers to these questions will help create the outline of
what’s to be included in the plan and identify the players who
need to be involved.
Developing a Cooling Contingency
Plan
The critical success factors in the development of a Cooling
Contingency Plan are leadership buy-in and support,
understanding “critical needs” versus current needs; preparing
for a “worst case” scenario; developing, filing and practicing a
formal plan, and keeping the plan current.
Realizing the need for a plan, like any initiative, is the first critical
step of the process. The second is assembly of the team that
will develop the plan. A successful team will have covered all
the bases in terms of knowledge and experience – leveraging
expertise from both on-staff personnel and outside experts,
such as insurance providers, system and control manufacturers
and consulting engineers.
ISPE NEW JERSEY CHAPTER
Key components of the plan should
include provisions to:
• Document the current HVAC equipment in use, ranging
from critical HVAC system information to component
details.
• Identify potential sources of failure, the probability of
failure and document the cooling required to maintain
critical areas.
• Match specific equipment and all required connection
components needed to support critical areas. Determine
required response time frame and budget.
• Determine the appropriate location for the temporary
equipment and the logistics required to set it in place, as
well as electrical and water connection points”.
• How to adopt the existing system and controls to better
prepare the facility for the use of a temporary solution.
• File, review, train and update the response plan and
system specifics on a regular basis.
• Conduct periodic cooling contingency drills.
While examining the HVAC system during contingency plan
development, the team may find areas to improve the system’s
operation, reliability or energy efficiency. For instance, if the
critical components are aged or have become unreliable,
it may be prudent to overhaul or repair them. There also
may be substantial benefit in upgrading or replacing existing
components with reliable, more energy efficient solutions. These
opportunities are worth investigating as they could provide
significant and immediate gains in efficiency, performance,
while providing a strong return on investment.
MDS Nordion, an international health and life sciences company
based in Canada, added an environmental cooling system for a
new radiopharmaceutical processing facility, and upgraded an
existing control system to provide complete facility environmental
documentation to meet strict U.S. and Canadian pharmaceutical
guidelines. As part of the project, the company formalized its
Cooling Contingency Plan and installed pipe stubs and valves
(Continued on page 4)
| N E W S L E T T E R Volume 14, No. 2 | PAGE 2
A Message From The President

Hello Everyone,
I hope you are enjoying the
return of the warm weather
as spring is now upon
us. At this time of year, I
can’t help but daydream of
baseball, golf, and Easter
candy for the kids.
This time of year also
brings us into the busy
season of ISPE events.
April starts off with a Dual Track program on Error Reduction
and Pharmaceutical Water & Steam on the 11th. We originally
advertised a third track to this program on Cleaning Validation.
However, due to a scheduling conflict with a training program in
Philadelphia being given by the national ISPE office, we had to
postpone our Cleaning Validation program. Look for this topic to
be covered at Chapter Day in June or at an event next season.
May brings us to the annual Golf Outing on the 9th at Farmstead
Country Club, followed by the Cardinal Health tour on the 17th
at the Cardinal facility in Somerset. These are two popular
events that are sure to sell out.
In total, that’s four events over the two months of April and
May. A lot of work and planning has been done to pull this off.
My sincere thanks go to Nandita Kamdar and Mike Wacks,
Programs Committee Co-Chairs; Joe Manfredi, Student Affairs
Chair; and Jerry Guillorn and John Postiglione, Golf Event
Coordinators. Without the volunteer efforts of these individuals
and many others behind the scenes, none of these events I get
to talk about would be possible.
Sincerely,
Jim Livolsi

Next up in April is the Student Poster Competition on the 26th.

This very exciting event will be held at Stevens Institute of
Technology in Hoboken. Entrants from Stevens, Rutgers and Integrated Systems
NJIT compete for a trip to the national competition at the ISPE Total Customized Solutions
& Controls, Inc.
Annual Meeting in Las Vegas. www.isc-website.com
� Consulting � System Integration
� Hardware Implementation � Technician Support
� Software Implementation � Metrology Calibrations
� Validation Protocols & Execution � Technical Writing
� Experienced And Versatile
Medford, New Jersey Pearl River, New York
(609) 714-8441 (845) 735-4751
info@isc-website.com

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 3

Cooling Contingency Planning (Continued from page 2)
at the mechanical plant to simplify installation of an emergency
chiller on very short notice, should the system lose a chiller for
any reason. Since the risk of a production loss due to the lack
of cooling was now much lower, the company received a major
reduction in a portion of the cost of its insurance premium.
fallout that a sudden, catastrophic HVAC system failure could
bring down upon a pharmaceutical manufacturer.
For more information, contact ISPE member Ed Szott, CEM, at
Trane in Parsippany at 973-434-2168 or ecszott@trane.com.

Conclusion Ed Szott is part of the NY/NJ

Energy Services team based
For pharma manufacturers, the successful implementation in Parsippany, NJ and is also
a Cooling Contingency Plan when called for is quite simply the Trane Rental Services point
“mission critical.” person for the Northern NJ area.
Mr. Szott joined Trane in June
Manufacturers that don’t properly prepare for an HVAC failure – 1999. His background includes
only to later suffer the consequences of one – face risks on two over 10 years experience as an
levels: FDA fines and legal actions for violating governance of estimator and project manager
building environmental conditions, and economic losses caused for several NJ based mechanical
by damage or loss of product inventory and/or production contractors.
downtime.

In terms of risk management, the advance planning and

preparedness involved in developing and providing ongoing
support for a Cooling Contingency Plan is clearly a smart
investment against the business, economic, health, and safety

parsons
200 Cottontail Lane
Somerset, NJ 08873
(732) 537-3500
Mobile: (609) 304-5796
Fax: (609) 953-5440
jack.balentine@parsons.com
Shannah Schodle
610-382-0057 Jack Balentine
shannah.schodle@crbusa.com Business Development Manager
www.crbusa.com www.crbbuilders.com
{ www.parsons.com

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ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 4

 Process Engineer/Process Development Specialist
Education and Experience Guidelines

• B.S. in Science, Pharmacy or Chemical Engineering.

M.S. or Ph.D. highly preferred

• 3-5 years experience in pharmaceutical formulation,

Location: Tri-State Area process development, or manufacturing technology
Level: Temp-to-hire
Products: Pharmaceuticals Please Contact:
Lewie Casey
Job Summary Med Exec International
800-507-5277/818-552-2036 ext 424
• Process development and validations execution. Email: recruit@medexecintl.com

• Batch test and Quality Control

• Protocols development

• Manufacturing support

• Report Writing

• Lead process improvement and scale-up operations

• Raw material sourcing

• Excipients and APIs knowledge

• QA Support

• Specifications analysis

• Evaluation, selection, and set up of state-of-the art

manufacturing equipment systems

CE&IC
serving the chemical & pharmaceutical industries since 1984

SCOT T. SHULTZ
Business Development

two terri lane • suite 125 • burlington, new jersey 08016

phone 609-387-1700 • fax 609-387-9322
E-mail: sshultz@ceicinc.com
ENGINEERING • DESIGN • AUTOMATION • VALIDATION

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 5

New Jersey Chapter – Upcoming Events for 2007

Date Time Event Location

Thurs April 26, 2007 4:30 pm Student Poster Competition Stevens Institute of Technology
Hoboken, NJ

Wed May 9, 2007 1:30 pm Golf Outing Farmstead Country Club

Lafayette, NJ

Thurs May 17, 2007 5:00pm-8:00pm Cardinal Health Tour Cardinal Health
Somerset, NJ

Wed June 13, 2007 9:00am-6:00pm NJ Chapter Day Holiday Inn, Somerset, NJ

Refer to the New Jersey Chapter Web site

http://www.ispe.org/newjersey for the latest Schedule of Events.

Consulting Engineers * Planners * Civil

* HVAC * MEP * Environmental

CORPORATE HEADQUARTERS:
Eleven Tindall Road,
Middletown, NJ 07748
732.671.6400 f: 732.671.7365
Offices in New Jersey / Puerto Rico
Contact: Stephen Tomicki

www.tandmassociates.com

TRIDENT ENGINEERING, INC.

Planning • Design • Validation

Amy Henderson Caldwell

267.685.1700, ext. 322
acaldwell@trident-engineering.com

www.trident-engineering.com

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 6

Welcome New Members
Mrs. Victoria O. Aina, Procter & Gamble Pharma Mr. Niranjan P. Padia, Stevens Institute of Technology

Mr. John Dennis Anderson, CH2M HILL Mr. Hitarth J. Patel, Stevens Institute of Technology

Ms. Karen L. Baldwin, Critical Path, Inc. Kandarpkumar A. Patel, Stevens Institute of Technology

Mr. Robert L. Banda, P.E., RLB Engineering Mr. Kenneth A. Pors, Schering-Plough Corp

Mrs. Bhavna Bhatt, PharmEng USA Inc. Ms. Michelle K. Price, Rockwell Automation

Mr. James J. Cargilo, Image Solutions, Inc Mrs. Stephanie Price-David, Johnson & Johnson

Mr. Edward D. Coleman, Schering-Plough Corp Holly Randolph

Mr. Gary S. Dacosta, Currie & Brown Mr. Scott A. Rowohlt, Sordoni Construction Company

Mr. Richard Doyle, Bristol-Myers Squibb Steven M. Sarb, Reckitt Benckiser

Mr. Joe Fairfield, Baxter Mr. Mathur B. Savaliya, Stevens Institute of Technology

Peter M. Frempong, New Jersey Institute of Technology Ms. Margot Sharapova, GE Healthcare, Medical Diagnostics

Mr. Mark Ganser, Phyton Ronald E. Sullivan, Business Transformations

Dr. Erik Gordon, Stevens Institute of Technology Mr. Michael A. Thomas, General Aire Systems

Y Ian Handel, Stevens Institute of Technology Mr. David D. Troutman, Oliver M. Dean, Inc.

Ms. Lauren Heading, Informa Healthcare Evangeline Tzatzalos, Rutgers University

Ms. Tamla P. Hill, Wyeth Mr. Hitesh Kumar V. Vadi, Stevens Institute of Technology

Mr. Lawrence A. Klusmier, Spirax Sarco Inc Yury Voloshin, Stevens Institute of Technology

Mr. Pallav V. Lodhia, Stevens Institute of Technology Mr. Frank G. Weber, Perlen Converting LLC

Jimmy M. Lu, Schering Plough Corporation Mr. Paul B. Wernke, Jr., Cordis Corporation

Mr. John Lyons, GL Engineering Mr. George M. Wolf, Wyeth

Scott Matthews, Pharma-Sys, Inc.

Mr. Scott McGurl, Siemens

Robert Migliore, BMS

Mr. Brian OConnor, The Whiting-Turner Contracting Company

COMMISSIONING VALIDATION

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5235 Westview Dr., Suite 105 • Frederick, Maryland 21703

Toll-Free 1-888-242-0559 • Office (240) 379-6444 • Fax (301) 696-9695

1-877-4-JMOORE www.propharmagroup.com

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 7

Upcoming ISPE International Events
For details, please go to ISPE’s Global Calendar at www.ispe.org.
May case studies on MES systems and the use of virtual machines
21 May 2007 - in a GxP environment. Interactive sessions include a question
25 May 2007 5th Annual Bioprocessing Institute and answer panel discussion, as well as special interest group
break-out sessions. Cambridge, Massachusetts
Practical knowledge and best practices for biotechnology
professionals. Philadelphia, Pennsylvania November
November 2007 4 Nov 2007 - 7 Nov 2007 2007 ISPE Annual
June Meeting
4 June 2007 - 7 June 2007 2007 Washington Conference
“Delivering Today, Transforming Tomorrow” is the theme of this
Facilities Summit, ISPE/FDA co-sponsored interactive year’s Annual Meeting. Join pharmaceutical innovators from
seminar on Product Quality Lifecycle Implementation (PQLI), around the world for the premier opportunity of the year to
Barrier Isolation Technology Forum, the latest on successful network with an international roster of industry professionals.
containment technology, and much more. Arlington, Virginia Check back regularly for complete details and on-line
registration. Event includes networking receptions, table top
September exhibits, and sponsorship opportunities. Las Vegas, Nevada
10 September 2007 - 13 September 2007 Boston Training
Series

Skills and practical knowledge for biotechnology, regulatory,

HVAC, and GAMP professionals. Cambridge, Massachusetts

12 September 2007 GAMP Americas Forum

The GAMP® Americas Forum on offers the latest on GAMP and

current activities of the GAMP Americas special interest groups.
It focuses on manufacturing systems compliance and several

Solutions for the

Bio/Pharmaceuticals Industry
Stantec provides cGMP Facilities Design, Compliance,
Process Design, and Control System Integration
through leading-edge solutions to companies involved
AD-CA-WSA-2007APR02-P1V1

in the discovery, research and development, and

commercial-scale manufacturing of pharmaceutical,
biotechnology, and medical device products.
In North America, call Mike Varrone at (631) 424-8600 or
mike.varrone@stantec.com

Engineering • Architecture • Project Management

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 8

 The ISPE New Jersey Chapter 2006/2007 Board of Directors
President Jim Livolsi, Wyeth Ayerst Pharmaceuticals, (845) 602-4203, livolsj@wyeth.com

Executive Vice President John Postiglione, (908) 672-3238, Spirax Ultra Pure, jpostiglione@spiraxultrapure.com

Vice President Dragutin Stoicovici, Cozzoli Machine Co., (732) 564-0400, dstoicovici@cozzoli.com

Treasurer Gordon Leichter, Pharmadule, Inc., (908) 470-1023 x14, gordon.leichter@pharmadule.com

Secretary Scott Hickok, Middough Consulting, (858) 866-6580, hickokrs@middough.com

Directors Walter Smyth, Holt Construction Corp., (973) 854-6381, wsmyth@flholt.com

Matthew Ferrier, Commissioning Agents, Inc., (860) 961-4311, matthew.ferrier@cagents.com

Luke DeMayo, Paulus, Sokolowski and Sartor, (732) 584-0522, ldemayo@psands.com

Steve Fries, Wyeth Research, (732) 274-4251, friess@wyeth.com

Nandita Kamdar, Paulus, Sokolowski and Sartor, (732) 584-0449, nkamdar@psands.com

Peter Koza, Discovery Labs, (908) 740-4864, petekoza@optonline.net

Immediate Past President Janit Buccella, Regulatory Compliance Group, LLC, (908) 310-2941, janitb_rcg@mac.com

Chapter Manager Lorraine Gallo, Paulus, Sokolowski and Sartor, (908) 325-0345, manager@ispenj.org

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ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 9

2006-2007 Chapter Committees
Awards Membership Programs
Chair: Co-Chair: Co-Chair:
Steve Fries Jerry Loehr Nandita Kamdar
Wyeth Research McNally International Co. Paulus, Sokolowski & Sartor
Tel: (732) 274-4251 Tel: (973) 591-0977 Tel: 732-584-0449
friess@wyeth.com jloehr@mcnallyintl.com nkamdar@psands.com
Co-Chair: Co-Chair:
Communications Linda Jones Mike Wacks
Chair: AES Clean Process Vision Consultants, Inc.
Matthew Ferrier Tel: (215) 393-6810 x 112 Tel: (973) 258-0404
Commissioning Agents, Inc. ljones@aesclean.com processvision@verizon.net
Tel: (860) 961-4311
matthew.ferrier@cagents.com Newsletter Student Affairs
Co-Chair: Editor: Co-Chair:
Peter Koza Scott Hickok Joe Manfedi
Schering-Plough Middough Consulting GMP Systems
Tel: (908) 740-4864 Tel: (858) 866-6580 Tel: 973-575-4900
petekoza@optonline.net hickokrs@middough.com jjm1152@aol.com
Communications: Co-Chair:
Community Affairs Matthew Ferrier Tom Malone
Co-Chair: Commissioning Agents, Inc. Tel: (609) 651-0907
Janit Buccella Tel: (860) 961-4311 temalone@patmedia.net
Regulatory Compliance Group matthew.ferrier@cagents.com
Tel: (908) 310-2941
Advertising:
Survey
janitb_rcg@mac.com Co-Chair:
Gordon Leichter
Co-Chair Pharmadule, Inc. Walter Smyth
John Postiglione Tel: (908) 470-1023 x14 Holt Construction Corp.
Tel: (908) 672-3238 gordon.leichter@pharmadule.com Tel: (973) 854-6381
jpostiglione@spiraxultrapure.com wsmyth@flholt.com
Nominating Co-Chair:
Education Co-Chair: Mike Varrone
Co-Chair: Bruce Eckman Stantec-Bio/Pharmaceuticals
Jim Livolsi Torcon, Inc. Tel: (631) 424-8600 x357
Wyeth Pharma Tel: (908) 232-8900 mvarrone@stantec.com
Tel: (845) 602-4203 beckman@torcon.com
livolsj@wyeth.com
Co-Chair:
Technology
Co-Chair Janit Buccella Chair:
John Postiglione Regulatory Compliance Group Gordon Leichter
Tel: (908) 672-3238 Tel: (908) 310-2941 Pharmadule, Inc.
jpostiglione@spiraxultrapure.com janitb_rcg@mac.com Tel: (908) 470-1023 x14
gordon.leichter@pharmadule.com
Marketing
Chair:
Dragutin Stoicovici
Cozzoli Machine Co.
Tel: 732-564-0400
dstoicovici@cozzoli.com

If you are interested in assisting on a committee, please contact Jim Livolsi or the committee chair.

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 10

February 2007 Event

“National Engineers Week at

Jersey Gardens Mall”
National Engineers Week was well attended by young
future Engineers at the Jersey Gardens Mall in Elizabeth,
NJ. ISPE members along with our friends in ASCE
volunteered to participate in Engineer’s week events on
February 18th and 24th. This event was fun for both the
members, adults, and kids and is another good way of
promoting engineering to young people!
Patrick Jones

Activities included:

• Gum Drops Engineering in which children learned

about building a stable structure. The concept
between the strength of a square versus a triangle
was great for their first taste of engineering.

• Bunny Copters - Kids were exposed to how

different lengths/shapes of bunny ears affected how
fast the bunny copter spun and how long it stayed
in the air.

• Paper Bridges children learned how to manipulate a

piece of paper to provide the greatest strength and
competed to engineer a bridge that could hold the
most pennies. P. Jones Engineer Day

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ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 11

Career Doctor Don Answers Your Questions
Q. 1: Should I attend job fairs to enhance my job search?
Z. K. (NY)
A. 1: My answer is a qualified ‘yes.’ Check in advance to
make sure that the job fair has been organized by a reputable
organization in your field. If there is an admission charge, I
would be very wary because it sounds like a money-making
proposition by some fly-by-night organization. Look at the list
of participating companies. I would also suggest that you visit
the job fair a little earlier in the day when all participants are still
fresh. Squeezing in a visit during the crowded lunch hour or late
in the evening after work can be counter productive.
Do not visit every single booth, dropping off your resumes, using
a ‘buck shot’ approach. A targeted and focused ‘single bullet’
approach is needed. What I mean is that you assign priorities
with your time spent there by visiting only the companies in your
field you would like to work for. Study up on these companies
through their websites and annual reports. This way you
can ask intelligent questions about the companies you are
interested in.
Many of my clients have secured jobs in all fields because
they were able to chat and connect with the hiring manager or
the supervisor they ended working for. So, take this venture
seriously. Have multiple copies of your resume, even several
resumes with different targets and job objectives. Polish up
your ‘elevator speech’ or ‘personal infomercial.’ This speech
should be custom-tailored to the situation and brief -- 30-60-
90-120 seconds. Make sure to obtain the business cards of the
contacts you made and send them thank you notes within 24
hours, also asking for face-to-face interviews. And be sure to
follow up with telephone calls!
One last hint! Networking is still one of the best ways of getting
a job, so beware of hopping from one job fair to another, and
losing precious job search time which can be used profitably
elsewhere.
Q. 2: I am about to graduate from an engineering school. What
are your thoughts on the effectiveness of company recruiters
visiting the campus, and my own college Career Services?
P. R. (NJ)
A. 2: In my opinion, college career services at most educational
institutions do a very good job. They try to bring the parties
together, namely, graduating seniors (and people obtaining their
Master’s as well as Doctorates), and company recruiters visiting
their campus. Do not expect career services to hand you a job
on a platter! It is up to you as a candidate to sell yourself. It is a
sort of a mini job fair on your own campus.
Learn how to use the computerized and non-computerized
ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2
Don earned his MS degree in
Management from Kansas State
University, an IE (Professional)
degree in International Management
and Personnel Relations from
Columbia University, obtained New
York University’s postgraduate
Certificate in Adult Career Planning
and Development, and is a licensed
Professional Engineer in the State
of New Jersey.
resources in the career services office to your advantage. Career
guidance professionals are very knowledgeable and helpful.
Make sure you tap into this gold mine in your backyard.
Q. 3: I am the owner of a small service organization in the
construction field. One client is so nasty that they are wearing
out my people and lowering their morale. Do you think it would
be acceptable to complete a certain project and then drop
them permanently, not doing business with them any more?
J. T. K. (CT)
A.3: This is a very tough question to answer! Have you tried to
bring this nasty behavior to their attention at a very high level,
in a diplomatic way? Do you have an inkling that these nasty
characters are pretty much on their way out? If that is the case,
you may be able to grin and bear it a little longer for the sake of
your financial stability.
If your stream of income is sufficient and all other efforts to
control this situation have failed, I would not hesitate to sever my
business relationships with that client. Your people should not
be disrespected and abused. If they are burning out and leaving
your company, it behooves you to drop that client, because you
will be better off without that client in the long run anyway.
One last thought. Since you are a small company and many
lives are involved in terms of livelihood, I would consult with your
trusted advisors and employees before taking a very drastic
step of dropping a client. I am optimistic and confident that if you
close a door for a good reason, a large window will open!
[Special note: Please send your career-related questions to
don@careerquestcentral.com and also visit our website at
www.careerquestcentral.com. Questions will be selected based
on their contemporary nature and general interest. We regret
we will not be able to send individual replies as in the past,
because of the large volume of domestic and international e-
mails. Your patience and understanding are appreciated.]
| PAGE 12
February 2007 Event

“Baxter BioPharma Solutions 2006

Facility of the Year Award Winner”
In February, the chapter returned to the Holiday Inn in Somerset,
New Jersey for the presentation of the prestigious 2006 Facility
of the Year Award to Baxter BioPharma Solutions for their Phase
IV Syringe and Vial Filling Facility. The event had an excellent
turnout with over sixty Chapter members in attendance.

The presentation began with Andrew Signore, PE, PMP,

DBIA (Co-founder & President of Integrated Project Services)
providing an overview of the award and introduced one of the
Judges, Ulrich Rudow (VP of Worldwide Engineering & Real
Estate at J&J). This Award is sponsored by ISPE, INTERPHEX,
and Pharmaceutical Processing. (L to R) Joe P., Gordon L., Ulrich R.

Mr. Rudow spoke about the process in which the ISPE

committee reviewed and judged the facilities that were entered
into the contest. “One of the most important things” Rudow
stated, “is for entrants to be quite specific about their project
requirements, timelines, and costs.” Providing this information
aided judges in determining if a project was successful in
fulfilling a company’s goals and stayed within budget. The
Baxter facility, which utilized an integrated project delivery
process and the Pharmadule modular construction technology,
was chosen because of the technological innovation utilized,
the speed, cost efficiency and quality, and the decision making
process that made the project an overwhelming success.

The third speaker of the evening was Gordon Leichter, Ph.D.,

(Director of Business Development at Pharmadule, Inc.). Dr. Vicky Lemons raffle winner
Leichter spoke about the engineering excellence that the award
typifies, and provided the five criteria that are looked at while He provided a brief overview of the five companies that were
judging the 15 contest entries: contest finalists:

1. Ergonomics 1. Astra Zeneca / UK

2. Contribution to industry through the use of technology
3. Uniqueness
4. Quality (fit & finish) as well as cGMP compliance
5. Overall project execution
2. Daiichi Asubio Pharma / Japan
3. Janssen Pharmaceutica / Belgium
4. Wyeth Pharmaceuticals / Ireland
5. Baxter Large Scale Sterile Manufacturing (aseptic syringe
fill) / Bloomington, Indiana

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 13

The Detailed Design phase of this project began in July 2003
and the Process Qualification phase began in March 2005
for an overall project time of only 22 months. (Prior to July
2003 approximately a year was spent in the conceptual and
preliminary design phase.) Costs were well within budget with
a budgeted amount for validation of $125 Million and an actual
cost of $116 Million or ~7% under budget. Although modular
construction costs are approximately 10- 15% higher that
conventional stick built construction, overall project costs can be
Andrew Signore
reduced by up to 40% using the modular technology because
decisions are final once construction begins.

The Baxter facility project consisted of both new construction

as well as renovation of existing facilities that increased their
syringe filling time from 300 to 500 syringes per hour for an
increase in efficiency of 60%. The Pharmadule modular
construction technique was discussed in detail sharing the
fact that each module is constructed and qualified in Sweden,
saving large amounts of time during construction and validation.
Shipping of these modules is non-problematic being that they
are a standard container size of 14.5’ height x 14.5’ width x 45’
length making highway transportation to the site feasible.

The Baxter and Pharmadule teams who worked on this project

had been involved in past projects together, significantly
reducing the learning curve required in a large project such as
this. A successful FDA walk-through occurred in May 2005. Ulrich Rudow

This month’s Raffle winner was Ms. Vicky Lemons of Teratec.

When the Diagnosis is

Pharmaceutical or
Laboratory Construction,
See a Specialist.

CONSTRUCTION MANAGERS
Gordon Leichter
& GENERAL CONTRACTORS
Westfield, NJ � Guaynabo, PR � Philadelphia, PA
www.torcon.com

ISPE NEW JERSEY CHAPTER | N E W S L E T T E R Volume 14, No. 2 | PAGE 14