Project Manager Engineer
Resume:
Jack Walsh
Hoffman Estates, IL 60169
M 847 845 - 9163
abmq70@r.postjobfree.com
**/**** ** *******: Independent Consultant (1099 / W2):
. CSL Behring, Kankakee, IL (01/10 - 03/10)
Validation Consultant (ASI)
Validation activities for the Alpha-Proteinase Inhibitor (API) Virus
Removal Filter Replacement Project.
o Completion of documents and execution of Performance
Qualification (PQ) protocols to evaluate the automated Clean-In-
Place (CIP) process associated with the Planova Filtration and
Diafiltered UF Concentrate Systems.
o Validation activities for the mixing (post-pooling) of
Pasteurized API Solution
. Hospira - McPherson, Kansas (10/09 - 11/09)
Validation Engineer/Consultant (Compliance Partners/RCA)
Gap Analysis of existing documents and PFMEA for the M17 vaccine
manufacturing operations utilizing isolation technology
. Consulting on Business Development Objectives 01/09 - 05/09
Consultation on interim basis (Compliance Partners)
. Merck, Bio/Sterile Validation, West Point, PA. (09/08 - 10/08)
Project Manager/Schedule Oversight (Coda Corp. USA)
Project Management for the Bio Sterile Validation (BSV) Group to
complete corrective actions as a result of a Warning Letter.
. St. Jude Medical, Inc.- Atrial Fibrillation Division, Minnetonka, MN.
(05/08 - 08/08)
Sr. Validation Engineer/Consultant (Compliance Partners)
Development of validation documentation for a medical device
manufacturer
Documentation developed in Project Document Management (PDM) System
(Windchill)
o Process Validation / Re-Validation Plan Template
o Process Fail Mode Effects Analysis (PFMEA) for Response &
Supreme Catheters
o PFMEA Report for Response & Supreme Catheters
o Process Validation / Re-Validation Plan - Response & Supreme
Catheters
o Process Flow Diagrams (PFDs) for Livewire Catheters (3)
o Equipment Specifications
. FERRO Pfanstiehl Labs, Waukegan, IL (01/08- 03/08 )
Sr. Validation Engineer (Compliance Partners)
Development of documentation for upgrades of facility /
systems for a manufacturer of APIs & Excipients:
o IQ/OQ/PQ Class 100,000 manufacturing areas (2)
o IQ/OQ HVAC System for Class 100,000 Manufacturing areas (2)
o IQ/OQ/PQ for USP Water System Modifications (2)
. sanofi pasteur, Swiftwater, PA (09/06 - 11/07)
Sr. Validation Engineer (Jacobs Engineering)
Validation Lead - Clean Utilities, for a new (green field) Flu Vaccine
manufacturing facility
o Review & approval of Engineering Turn Over Packages (ETOPS)
o Development of "Leveraging" documentation for commissioning
(I/O, Alarm & Loop Tests)
o Development of IOQ documentation for the Clean Utilities for the
New Influenza Vaccine Manufacturing Facility (NIVMF)(Documents
developed in Documentum.(Windchill)
o Pre-treatment & Process Water System (IOQ)
o WFI Generation (IOQ)
o WFI Storage & Distribution (IOQ)
o WFI Cold Drops System (IQ)
o Process Water Distribution System (IOQ)
o CCA Distribution (IOQ)
. Boston Scientific, Spencer, Indiana (5/06 - 8/06)
Technical Specialist (Compliance Partners)
o Development of validation documents for equipment / tools used
for manufacturing medical devices. .Documentation developed in
Project Document Management (PDM) System (Windchill).
o 7/2006 - Recipient of two (2) Boston Scientific Spencer,
"Positive Action Certificates" in recognition of efforts put
forth in assignments.
. Stryker Orthopaedics - Mahwah, New Jersey: (5/1/06 - 5/19/06)
Technical Consultant (Oxford / CSSC)
o Development of a Risk Assessment (FMEA) document for proposed
cleanroom installation for medical device manufacturer.
o Development of a User Requirements Specification (URS) for a
proposed cleanroom
. Meridian Medical Technologies - St Louis, MO:(12/05 -3/06)
Validation Consultant (Compliance Partners)
o Development of Re-Qualification documents for HVAC systems (5).
o Development of Re-Qualification documents for clean rooms (5).
o Development of Re-Qualification documents for Pure Steam
Generators (3)
. GE Healthcare, Biosciences, Arlington Heights. Illinois: (6/05 -
12/05)
Project Manager (ESPO Eng)
Project Manager for the new cyclotron installation project:
(Radiopharmaceuticals)
o Specifications, purchase and installation of internal components
for "hot cells" associated with the manufacture and finished
packaging of Thallous Chloride 201.
o GAP Analysis for the manufacturing process for Thallous Chloride-
201
o FMEA exercise for cyclotron installation.
o Development of P & ID Drawings to show the process flow on Hot-
Cell process boards used in the manufacture of Thallous Chloride-
201
o Development of the process narrative to facilitate the
programming necessary to automate the manufacturing process to
include specifics for the HMI Control Screens/Panels
o Development of the Factory Acceptance Test (FAT) documents for
each of the "Hot-Cells".
o Development of the Site Acceptance Test (SAT) documents for each
of the "Hot Cells".
. Terumo Cardiovascular Systems, Ann Arbor, Michigan - (3/05 - 5/05)
Validation Consultant (Serentec)
Validation activities and validation / cGMP Gap Analysis' activities
for a Medical Device Manufacturer:
o IQ & OQ for a new AHU
o Gap Analysis for existing manufacturing rooms
o Gap analysis for existing UF Water System
. Development of Validation Documents for confidential clients (10/04 -
12/04) (PITA):
o Validation Master Plan & Revalidation Master Plan
o IQ for Sterile Air handling Unit
. Eli Lilly, Indianapolis Indiana, (4/04 - 9/04)
Conducted various validation activities associated with the
B105 "Mega Shutdown" expansion project: (Comply LLC
/ IPS)
o Engineering Turn Over Packages (ETOPs) for SAH-1 & SAH-4
o Commissioning, IQ & OQ for SAH-1 & SAH-4
o Commissioning, IQ & OQ SAH-2, SAH-3 & SAH- 8.
o Commissioning, IQ & OQ for Differential Pressure Monitoring
System
o Commissioning & ETOP for all Electrical Distribution Systems for
the B-105 upgrade
. Cardinal Health BSLS, Humacao, Puerto Rico (1/04 - 2/04) (Protocol
Link)
o Conducted the PQ of a Finn-Aqua autoclave for Abbott
Laboratories
. Chesapeake Biological Laboratories, Baltimore, MD. (05/03 - 1/04)
(Protocol Link)
o Responsible for the cGMP and Validation Gap Analysis of the
Depyrogenation Ovens at a biological operation that was recently
inspected by the FDA.
o Responsible for the cGMP and Validation Gap Analysis of the
Water Systems (Pre-Treat & WFI) of a biological operation that
was recently inspected by the FDA.
. Alpharma, Baltimore, MD (11/02 - 3/03) (Protocol Link)
o Responsible for the survey of the water system (USP) to verify
compliance and accuracy of associated documentation.
o Assisted in the validation of new load-cells weighing systems
for compounding-tanks.
o Siebert Engineers, Lombard, IL 12/00 thru 11/01
Project Manager:
On assignment at Nabisco Biscuit Company, Chicago, IL
Completion of various projects related to the operations within the
world's largest bakery. Projects included:
o Upgrading of an existing chilled-water system to support
production increase.
o Installation of a new Cleaver-Brooks 900 BHP Boiler.
o Installation of a new Urschel grinder to rework 'DoubleStuf'
product.
o Installation of a new dicer to support special specifications
for Oreo bits for use in ice cream.
. US Consultancy Group, Oak Brook, IL 1/98 - 12/00
Lead Project Manager:
Responsible for the coordination of the consolidation of eight
beverage manufacturing plants into three plants for American Bottling
Company - Cadbury Schweppes, now part of DPSU Group- Dallas, TX.
$37MM.
This effort included coordination, and direct management of the
following:
o Salvage of existing process equipment for reuse in the plants to
be expanded - fillers, warmers, casers, palletizers, and related
conveyors
o Salvage of existing refrigeration equipment (ammonia) for reuse
in the plants to be expanded - compressors, condensers,
receivers and related piping and controls.
o Completed the development of bid packages, specifications and
contractor discussions concerning the expansion of buildings,
installation of water treatment systems (RO); upgrading of
refrigeration systems (Ammonia); and the design & installation
syrup processing systems for three beverage manufacturing
facilities that were part of the consolidation venture.
Assignment included final design specifications for the
construction required all three locations of the project.
o Completed the start-up of the support systems and the can/bottle
lines that were installed in each location. Chicago, - Columbus
Ohio - Ottumwa Iowa.
. Gensia Laboratories, Ltd., Irvine, California 3/97 thru 10/97
Manager of Facilities Engineering:
o Total responsibility for the completion of the construction of a
new oncology manufacturing facility $23MM. Assignment included
assisting in the development of IQ, OQ and PQ documentation
necessary for the validation of the facility and serving as a
part of the sign-off team for the validation documents.
o Total responsibility to define scope and determine budget for
the remodeling of laboratory space within the current
manufacturing facility $400K.
o Total responsibility to define scope and determine budget for
the remodeling of existing administration area in the main
manufacturing facility $300K.
o Total responsibility to determine scope and establish schedule
for the 1997 Shutdown scheduled preventive maintenance and other
project work for existing manufacturing facility.
. SoloPak Laboratories, Elk Grove Village, Illinois 6/95 thru 3/97
Staff Engineer / Project Manager:
o Total responsibility for the completion of the Elk Grove Village
expansion project $6 MM. This project consisted of the selection,
installation and startup of the following:
Equipment/Systems: New 3,000 AMP, 480 Volt power supply New
Fedegari FOF/6 Autoclave 86cu.ft.chamber new dual water softeners,
connecting to a single carbon bed feeding a new Zenon Reverse
Osmosis Unit. New 850 gal. RO Water Storage Tank with level
controls. New Stilmas 1500S Multiple-effect water still 900 gph,
feeding a DCI 1,000 gal. WFI Storage Tank, feeding a new WFI
Circulating Loop. New Finn/Aqua Pure Steam Generator. New 200 hp
Cleaver/Brooks Process Boiler. New Filling Line: 2ml @ 300 vpm,
200ml @ 50 vpm. New Cozzoli AW400 Vial Washer. New Despatch
Depyrogenation Tunnel New TL Systems 2700 filling/stoppering
machine. New West Capper. New Eisai Inspection machines (2). New
Garvey Conveyors.
o Assignment included Factory Acceptance Tests (FAT) and assisting in
the development of IQ, OQ and PQ documentation necessary for the
validation of the equipment/systems.
o Served as a part of the sign-off team for the validation documents
for the equipment and systems.
Construction work: Expansion of existing Component Preparation
Area. Construction of two new Gown-up Rooms 10K & 100K.
Construction of a new Sterile Storage Room 10K
Expansion of an existing storage room for conversion to a Filling
Room 10K w/ Class 100 filling envelope
Modifications to existing Compounding Area to create another Mixing
Room.
Relocation of existing Terminal Sterilizer.
o Selected to be a member of a Pre Approval Inspection PAI Swat Team
that was established to prepare the facility for several FDA
inspections. This assignment involved detailed inspections of
critical systems and review of documentation to ensure compliance
with all applicable policies and regulations. Assignment included
assisting in the development of IQ, OQ and PQ documentation
necessary for the validation of the facility.
o Served as a part of the sign-off team for the validation documents
for the facility.
. Webber/Smith & Associates, Lancaster, PA. 12/92 thru 6/95
Lead Process Engineer:
Responsible to define the Scope of Work required to meet the Client's
objective and develop the strategies, plans and/or specifications
required to complete the scope within specific time frames and
budgets.
Overall experience included projects for:
o Sweet Streets Desserts, Reading PA - Consultation and conceptual
design, with emphasis on food safety issues, for major expansion of
production facility with primary emphasis on the design and
installation of a new Variable-Retention-Time VRT freezer -
utilizing ammonia as the refrigerant, Daub oven and related support
equipment.
o Cadbury Beverages, Aspers, PA - Consultation and conceptual design
team for the design and construction of a Class-100, 000 Clean Room
for housing of new sterile filling operations.
o Kunzler & Company, Lancaster, PA - Consultation, conceptual design,
and USDA review of a major expansion of meat processing facility
hot dogs, sausage and hams.
o Southwestern Public Service Company, Amarillo, TX - Complete,
extensive, feasibility study of the dairy industry for Eastern New
Mexico and the Texas panhandle area. Major emphasis on the
producer farmer aspects of the business with a secondary emphasis
on the manufacturing aspects and projected costs for a conventional
cheese manufacturing facility with a capacity of 1,000,000 pounds
per day of raw-milk.
o au bon pain, Boston, MA - Complete feasibility study for a major
expansion of production capacity new plant to include: distribution
analysis, geographical location, site selection, conceptual design
of a new facility, and process & manufacturing review.
o Schreiber Foods, Inc., Tempe, AZ - Consultation and conceptual
design for a major expansion of an existing Cheese For
Manufacturing (CFM) operation.
o Odom's Tennessee Pride Sausage, Little Rock, AR - Complete review
of existing operations of a hog slaughtering operation to define
needs for a major expansion of operations.
Consultation on USDA requirements and formal presentation to USDA,
Washington, DC on final design specifications for the expansion.
o Mid-America Dairymen, Inc., Springfield, MO
o Portales, New Mexico - Consultation and conceptual design for
the expansion of an existing milk-evaporation operation to
evaporation & drying operation, with long term plans for the
addition of conventional cheese making and whey processing.
o Superior, Nebraska: Consultation and conceptual design for
the consolidation of shredded and diced cheeses operations
into one location with long term plans for the addition of
conventional cheese making and whey processing.
o Sargento Cheese, Plymouth, WI - Complete process review of existing
methods for the application of anti-cake material to various types
of shredded cheeses to improve performance and decrease costs.
o Leprino Cheese, Denver, Colorado
o Roswell, New Mexico - Consultation to Webber/Smith on design
and construction of a major expansion to an existing cheese
and whey manufacturing facility.
o Fort Morgan, Colorado: Consultation to Webber/Smith on design
and construction of a new cheese and whey manufacturing
facility.
o Milk Marketing, Inc., Cleveland, Ohio - Consultation and conceptual
design for the planned expansion of an existing cheese and whey
manufacturing facility (Farmers Cheese) with a capacity of
approximately 3,000,000 pounds per day of raw-milk with
consideration to requirements for continuous starter media
manufacturing (HTLT vs. batch processing), automatic brining
operations and updated packaging operations. Conceptual design and
development of an operational schedule for a new 6 bay receiving
area.
o Swiss Miss Foods, Menominee, WI - Consultation and conceptual
design for the installation of new aseptic processing lines for the
manufacture of pudding type products.
o Stella Cheese Co, Lincolnshire, IL Survey of existing operations
in several plants for the purpose of establishing criteria for
consolidating operations.
o Moyer Packing, Philadelphia, PA - Conceptual and final design of a
Carcass Rail System (CRS) for a major expansion of an existing beef
processing facility.
o Ben & Jerry's Ice Cream, St. Albans, VT - Development of equipment
purchases specifications for the powdered ingredients process
systems for a new (green field) ice cream manufacturing facility.
Complete review of Webber/Smith generated process P & ID drawings.
. Lyphomed Division of Fujisawa USA, Melrose Park, IL 3/90-12/92
Process Engineer / Senior Process Engineer:
. Responsible for the coordination and management of various projects
designed to improve productivity of a generic pharmaceutical facility
manufacturing injectable (parenteral) medications.
Equipment/Systems: Gruenberg Depyrogenation Oven. TL Systems 2700
Filler. Amsco Autoclaves. Terminal Sterilizers
Construction work consisted of the following: Terminal Sterilizer
installation. Construction of a new Biological Indicator Laboratory
including all equipment. Extensive remodeling of an Antineoplastic
laboratory. Construction of two new Gown-up Rooms10K & 100K.
Expansion of Component Preparation Area. Expansion of a Class 100
Filling Room Installation of Terrazzo flooring in several areas within
the facility.
1991; Awarded Chairman's Award in recognition of effort as Project
Engineer for BI Lab.
Kraft Foods, Glenview, IL 6/80 thru 3/90
Research & Development, Glenview, IL 2/84 thru 3/90
Pilot Plant Superintendent:
Managed all operations of the R&D pilot plant facility used for
identifying more cost effective methods of producing dairy products,
including frozen desserts, cultured products, process and natural
cheeses, and new dairy food products. Methods and equipment that were
developed were tested to ensure cost effective products without loss
of quality. Ensured all operations complied with corporate policies
of personnel management, safety, environmental protection and current
good manufacturing practices cGMPs.
1989: Received Senior Vice President's Letter of Commendation for
efforts put forth while serving as Chairman of the GMP Awareness
Committee.
. Kraft Foods, Operations Group, Melrose, MN 6/80 thru 2/84
Plant / Project Engineer:
Managed all engineering operations at a bulk cheese plant. Established
training programs for maintenance and production workers. Established
preventive maintenance and work-order programs for plant operations and
systems ammonia, chilled-water, and house-steam. Completed numerous
process enhancements within the plant. 1983: Awarded Kraft Production
Achievement Award in recognition for the effort put forth in the design
and installation of equipment which improved quality and increased
productivity in the manufacture of blue cheese.
INTERNATIONAL
Cardinal Health BSLS, Humacao, Puerto Rico (Protocol Link)
PQ of Finn-Aqua autoclave for Abbott Laboratories
. Fedegari Autoclave, Pavia, Italy (SoloPak)
Specification & Factory Acceptance Testing (FAT) of new autoclave for
SoloPak.
. Stilmas Stills, Milan, Italy (SoloPak)
Specification and Factory Acceptance Testing (FAT) for new WFI Still
for SoloPak
. Lacteos del Norte, SA, de C.V., Sabinas, Nuevo Leon, Mexico
(Webber/Smith)
Complete review of existing operations of a cheese manufacturing
facility with emphasis on cGMP, FDA and USDA requirements necessary to
bring the facility up to standards for acceptance of products into the
USA markets
. Al Safi Dairy est., Riyadh, Saudi Arabia (Webber/Smith)
Complete review of existing fluid & cultured operations with emphasis
on cGMP, FDA, and USDA requirements as a way of upgrading existing
operations and establishing specifications for the construction of a
new manufacturing facility for regional fluid and cultured products.
EDUCATION
. William Rainey Harper College, Palatine, IL 1985 - 1989
Courses in Business Management
. US Veteran
United States Marine Corps (USMC) 1966 - 1972
Honorably Discharged - Staff Sergeant (S/SGT) (E-6)
Quality Control Inspector - Airframes and Power Plants (F-4B, RF-4B &
EF-10B)
AFFILIATIONS
. Member of International Society of Pharmaceutical Engineers (ISPE)
since 1990
o 2010 - Selected by the ISPE-PCC Examination Development Committee
(EDC) to serve as a subject matter expert (SME) to assist the EDC in
developing examination questions (items) for the Certified
Pharmaceutical Industry Professional TM (CPIPTM) credential
examination.
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