David Swaim Jr.

Chemical Engineer

CAREER SUMMARY
I have more than 15-years of experience in the qualification of pharmaceutical
facilities. I have a firm grasp on industry standards, good engineering (and
construction) practices, GMPs, and equipment commissioning/qualification. I
bring both the design/build and regulatory agencies s perspective to the table.

EXPERIENCE
Owner’s Rep. Quality-Assurance Manager Schering (2006-2009)
As the Project Assurance Manager for the Summit NJ site, I developed a level-III quality
assurance program for the $500-million site expansion. Key activities included a Quality
Assurance Plan, Qualification Manual (including >200 construction quality data-sheets), project
procedures, audit program, rewards recognition program and an equipment RV/IV database.

Validation Manager Jacobs Engineering & Constructors (1999-

2005)
Department head-20-50 staff responsible for $45 million various IQ/OQ projects

• Manage project budgets • Support sales and marketing

• Audit projects • Train Staff and Field
• Develop Validation Master Plans personnel
• Design Qualification (DQ) • Create Project-specific
methodology Content Maps
• Conduct Design qualification • Gap analysis against industry
• Create a protocol library standards
• Create equipment master test • Developed Illustrated GMP
checklists training manual
• Biofilm point-man for Bio-
Processing Equipment (BPE)
Standard

Validation Field Manager Kvaerner-John Brown Eng. (1995-

1999)
Field manager for IQ/OQ execution teams of up to 20-staff

• Develop validation Master Plans
• Develop / execute IQ/OQ/PQ protocols
• Generation of SOPs
• Sales and marketing support
• Part-11 Compliance-MES Wonderware
• Bulk Biologics Bldg. (Pearl River NY)
• Oral Solid Dosage Bldg. (Suffern NY)
• Bulk API (Elkton WV)
• Bulk DTP / Yellow Fever Vaccines (Brazil)
• Automated Fill/Finish LVP (Sweden)
($8MM)
• Fill/Freeze/Finish Isolator (France)
($6.4MM)

Design/Development Senior Engineer (1989-1995)

Six-years of medical device design/development/qualification under QSAR design-
qualification GMPs. Qualification of liquid and solid filling lines, ALP form/fill/finish
equipment, and packaging lines. A complete history is available upon request

PROFESSIONAL ACTIVITIES
1. Authored the pharmaceutical risk-analysis chapter of the Baseline Guide for Packaging, Labeling
and Warehousing ISPE Speaker, seminar instructor on Design Qualification, and Change Control.
2. Member and speaker for the ASME Bio-Process Equipment (BPE) Standard biofilm committee.

davidgswaim@verizon.net
Validation Agents Inc.
david.swaim@me.com 1132 Wendler Circle
(610_-718-0658 Pottstown PA 19465
 David Swaim Jr.
Chemical Engineer

EDUCATION
• Chemical Engineering (BSChE) w/ Biochemistry Minor (first) Bucknell University
• MBA Pharmaceutical Studies (begun) Farleigh Dickinson University
• General Studies in Neurobiology Columbia University

Excellent References upon Request

davidgswaim@verizon.net
Validation Agents Inc.
david.swaim@me.com 1132 Wendler Circle
(610_-718-0658 Pottstown PA 19465