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
 Develop Validation Master Plans
 Design Qualification (DQ) methodology
 Conduct Design qualification
 Create a protocol library
 Create equipment master test checklists
 Train Staff and Field personnel
 Create Project-specific Content Maps
 Gap analysis against industry standards
 Developed Illustrated GMP 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.

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