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OBJECTIVE: Seeking projects that involve GMP or ICH Q7A
regulated, automated, chemical and/or biological processes, with the
opportunity to design, startup, commission and/or validate: Computer Systems,
Automated Processes, Process Equipment and/or Laboratory Equipment.
Del-Engineering Contract Engineer (6/92 –Present)
Clients
include:
Ohm Laboratories
Wrote
and executed IQ and OQ protocols for solid dosage manufacturing and packaging
equipment used for Generic Drugs.
Johnson & Johnson Ortho Clinical Diagnostics
Executed
cleaning validation IQ/OQ/PQ for the automated and manual cleaning of filler
pump parts.
Samuel Adams Brewery Breinigsville,
PA – SOP Writer
Wrote
Standard Operating Procedures (SOP) for processing beer and running CIP cycles
for the brewery.
GlaxoSmithKline Upper Merion/Upper Providence, PA –
Closed
out outstanding issues on executed protocols, shepherding documents through
final signature phase.
Advance Automation Associates
Wrote
FAT, SAT, IQ and OQ protocols for a Clean in Place (CIP) system for a
veterinary vaccine plant.
Trident Engineering
Analyzed
and sized condensers for alcohol recovery to comply with air permits using
AP42.
Wrote
and executed commissioning, IQ and OQ protocols for an API inhaled anesthetic
manufacturer.
Johnson & Johnson Ortho Clinical
Diagnostics
Reviewed
all of the Ortho Clinical Diagnostic (OCD) division’s validation documents for
a compliance gap analysis. Validation
document librarian for the duration of the project. Organized a validation records center for
faster document retrieval. Evaluated
each document for compliance to current GMPs (21 CFR parts 11, 58, 210, 211,
640, 820). Identified areas based on their
criticality to the process to determine where additional validation efforts may
be required to stay compliant with current regulatory environment.
Wrote
and executed IQ and OQ protocols for solid dosage manufacturing equipment used
for the Bristol Myers Squibb Co. Clinical Supply Operations Department for
compliance with GMP and European Union Regulations. Equipment included table presses, encapsulators,
pan coating equipment, automatic check weighers, a GLATT fluidized bed and
various sizing, milling and grinding units.
Wrote
and executed IQ and OQ protocols for API synthesis facilities. Equipment included a breathing air system for
operators, portable vessels and reactors that plugged into a S-88 based Delta V
DCS system.
Wrote
and executed IQ and OQ protocols for high containment laboratory facilities.
Equipment included two walk in containment hoods, operator breathing air, compressed
air, laboratory nitrogen distribution utilities, clean steam and process vacuum
system.
Merck
Wrote
and executed IQ and OQ protocols for Liquid Nitrogen system supplying cryogenic
tissue culture vaults.
Centocor
Wrote
and executed IQ and OQ protocols for a laboratory monitoring system that phoned
responsible personnel to notify them of alarm conditions.
Merck
Wrote
FAT protocols for a Delta V system for Merck’s HPV vaccine facility. This S-88
based facility included CIP, SIP, Media/Buffer prep and standard recipes.
Jacobs Engineering
Performed
on site engineering for Jacobs’ clients: Merck, Wyeth, Kimberly-Clark,
Eli-Lilly, and Schering-Plough.
Startup
and validation of a Wyeth project which was a two year 600 million dollar
Biotech facility at GI in
Merck
Project included validation of Apogee building automation system and process
compressed air for a varicella-zoster virus (VZV) HHV-3, vaccine facility.
Kimberly-Clark
project was the validation of a sample tracking system for a product stability
testing facility.
Eli-Lilly
project included IQ and DQ for an upgrade to the Humulin facility, which split
a WFI water system into two independent loops.
Schering-Plough
project was to organize preventive maintenance records for an up-coming audit.
Merck
Reviewed
computer systems for compliance with cGMP and Parts 11, 210 and 211
requirements. Audits included PLCs, Building Automation Systems, SCADA, LIMS,
Chromatography Systems, and custom software.
Applied
Control Engineering Inc.
Applied
Control Engineering Inc. is a system integrator serving the chemical and
pharmaceutical industries. Programmed
three Allen-Bradley PLC-5s adding new I/O and associated control logic for a
specialty chemical plant.
BioKinetics
is a design/build engineering firm serving the biotech and pharmaceutical
industries. Prepared Functional
Requirement Specifications (FRS) and Valve Sequence Tables (VST) for a project
with sixteen Allen-Bradley PLC-5/80s.
Wrote
FDA regulated automation documents including FRS, DDS, IQ, OQ, SAT, and
FAT. Supervised, as part of a team, the
construction of a $170 million pneumonia vaccine manufacturing plant. Had complete responsibility for a half
million-dollar skid within the fermentation suite. Shared responsibility with five engineers for
automating the $40 million fermentation suite.
The fermentation suite was controlled by both an Allen Bradley PLC, and
a DCS system.
Rohm
&
Responsibility
was a $1.5 million automated tank farm renovation. Ran the project from design through startup
while full-scale manual production was taking place. Prepared P&IDs taking them through
multiple approval cycles and reviews including production approval, safety,
health and environmental approval, and business team capital expenditure
approval. Supervised detailed design.
Coordinated the efforts of a team of piping, instrument, electrical and
structural designers in preparing all the drawings and details. Involvement with system startup including
tuning loops, stepping through sequences, water runs and chemical startup.
Honeywell
Added
INIT alarms to the HMI card and test the change. Programmed in Pascal. Tested code in CL.
Epsilon
Epsilon
is a polypropylene manufacturer.
Responsibility was to review the as-built programming for three
Honeywell IPC-623 PLCs against license.
American
Cyanamid
Assembled
and installed six different pilot scale (~25 gpm), ultra filters (UF), and
Reverse Osmosis (RO) units from three different vendors for evaluation of their
effectiveness in recovering trace levels of antibiotic remaining in the process
waste water.
Ecochem
Ecochem
was a DuPont and ConAgra joint venture to make biodegradable plastics. Responsibility was to supervise the 12 to
Chessell Inc.
Programmed in C, in a UNIX
environment, developing software for industrial equipment.
EG&G Princeton Applied Research
Programmed in
Rohm &
Production plant engineer
responsible for troubleshooting and de-bottlenecking processes.
EDUCATION & TRAINING
New Jersey Institute of Technology completed 96 credits out of 130 needed toward a BS in
Electrical Engineering GPA 3.9/4.0 (Night School 1987-1992) Tau Beta Pi
Stevens Institute of Technology completed
requirements for a Pharmaceutical Manufacturing certificate and a Validation
certificate (2009) in pursuit of a Masters of Pharmaceutical Manufacturing
through the Mechanical Engineering department GPA 4.0/4.0
Professional Engineer (1992) Licensed in PA, NJ and DE