Joseph Vault has over 30 years of experience in engineering, regulatory compliance, and program management across multiple industries. He currently runs his own regulatory consulting firm and has previously held senior roles at Ives Envision, Proconex, Honeywell, and CB Ives providing technical, validation, and quality management services to pharmaceutical and medical device clients. He has extensive experience developing and managing validation programs, performing regulatory assessments and remediation, and training clients on inspection readiness.

1. JOSEPH V. AULT
(610) 246-2220
jvault314@gmail.com
SUMMARY
Senior Engineering and Regulatory Compliance professional with proven program
management and business development capabilities seeking new opportunities to apply
30+ years industry experience across multiple environments including pharmaceutical,
chemical, specialty chemical, power and military.
SKILLS
Business and Service Development
>Program Development/Management
>Proven Senior Account Manager supporting hardware and services direct sales over 30 years
>Business development executive specializing in gaining market share and development of new clients
>Generating and supporting a wide portfolio of technical and regulatory products and services
>Sourcing, hiring, training and managing up to 60 employees per project across nine (9) countries
Technical
>Project Management
>Process Control Application Engineering
>Applied Fluid Flow System Application Engineering
>Process Control System Configuration, Implementation and Validation
>Data Acquisition System Design, Commission and Validate
>System Integration and Module Testing Plan and Protocol Development
>Technical and engineering training capability
Regulatory Compliance
>Generation of corporate, divisional and departmental Quality Management Systems
>Computerized System Validation Subject Matter Expert (physical and virtual systems)
>Laboratory SOP Development including assay SOPs as well as facility, systems and equipment SOPs
>Regulatory audit readiness evaluation and recommendation capability for biopharmaceutical corporate,
divisional and departmental groups worldwide
>Regulatory compliance remediation strategy development and execution
PROFESSIONAL EXPERIENCE
PERCEPTICORE, LLC 2004 – Current
Principal Member
Founded and managed a regulatory compliance consulting practice providing services worldwide to the
biopharmaceutical and medical device industries. Built profitable annual revenues > $4MM per year. The
firm focuses on audit and optimization of existing client computerized system validation (CSV) strategies,
development of new ground-up Quality Management System (QMS) frameworks including CSV and data
management and CSV and QMS remediation support when observations were documented by worldwide
inspectorate bodies such as the US Food and Drug Administration.
 Sourced and trained scientists with regulatory backgrounds and maintained them on an FTE basis to
operate as a cohesive unit under a unified Quality Management System internally.
 Directly employed 34 professional consultants in USA, UK, The Netherlands and Switzerland.
 Achieved Global Preferred Supplier status for Merck Sharpe & Dohme and GSK as well as 15
additional biopharmaceutical or medical device clients.

2. JOSEPH V. AULT
(610) 246-2220
jvault314@gmail.com
PERCEPTICORE, LLC 2004 - Current
Principal Member
(continued)
Representative efforts and sample of operational titles held follow:
o Senior Consultant, Charles River Laboratories
 Provided system analysis of an automated liquid handling system robotic system
 Identified technical gaps and corrected to allow system to pass integration testing
 Developed and executed CSV deliverables within new QA framework for Malvern
facility
 Generated a methodology for the validation of a gene mapping analysis system
including validation of analyses requiring comparison to existing United States
sequence libraries
o Senior Consultant, Genzyme Core Design Build Group
 Integrated Emerson Delta V PCSD configuration standard into the validation
deliverables
 Developed UAT test design and test protocols for Emerson Delta V platform
 Aligned testing approach with Genzyme risk assessment and system criticality
 Updated trace matrix to capture UAT details
o Senior Consultant, Genzyme Worldwide Engineering Standards Development
 Supported Genzyme Industrial Affairs to develop a worldwide unified engineering
approach and philosophy across four standards covering batch configuration,
engineering project methodology, process control systems and alarming.
o Validation SME, Genzyme Sharepoint Portal Validation
 Reviewed existing framework for prior Statistica deployment and validation.
 Evaluated Functional Risk Assessment and Trace Matrix to ensure all applicable
areas were incorporated into SOPs.
o Validation SME, Genzyme Process Data Warehouse Validation
 Responsible for analysis of existing controlled system state and development of
documentation in alignment with corporate and regional standard.
 Coordinated with project team to generate all required documentation under their
PUMA worldwide standard.
o Program Manager, Merck Research Laboratories Worldwide System Validation Team
 Developed and directly managed a CSV program under a unified approach across 7
countries.
 Reduced client spend on instrument validation support across 7 countries from $5-
6MM per year to $2MM per year.
 Program instantiated 2008 through 2013 and incorporate by Merck into their internal
laboratory instrument support programs under Perkin Elmer.
o Program Manager, Schering Plough Worldwide System Validation Team
 Developed and managed program to align 3000 laboratory systems worldwide with
US FDA Title 21 CFR Part 11
 Program featured rapid deployment teams for system and regulatory gap analysis
and remediation.
 Sourced, trained and managed 60 scientists and engineers worldwide across US,
Europe, Puerto Rico and Singapore

3. JOSEPH V. AULT
(610) 246-2220
jvault314@gmail.com
PERCEPTICORE, LLC 2004 - Current
Principal Member (continued)
o Project Manager, SP/Organon Clinical Study Server Virtualization Effort in Waltrop, Germany
 Developed the project plan and change management plan for the decommissioning
of a server supporting up to 200 clinical studies for Schering-Plough (formerly
Organon).
 Developed methodology for data migration from physical server in Germany to a
virtual array in Belgium establishing legally defensible compliance position for the
client.
o Project Manager, Merck Research Laboratories Antiviral Research Resistance Lab
 Managed new laboratory construction project for genotyping/phenotyping laboratory
supporting Merck Antiviral Research.
 Scope included support for development of financials and project charter approval
 Reported to the business area managing multiple vendors, central engineering
activities, MRL IT and scientific personnel
 Developed and executed validation deliverables including migration of data and
SOPs to the new laboratory space.
o Project Manager, MRL Divestiture Wayne, PA Laboratory to PPD
 Generated Merck Instrument Transition Plan supporting the divestiture.
 Executed the transition of 124 validated instrument and system platforms originally
implemented and validated by Merck but sold to Pharmaceutical Products
Development Inc. (PPDI).
o Project Manager, Merck Tsukuba Laboratory Divestiture
 Managed decommissioning and asset recover of 500 instruments in Tsukuba, Japan
both GxP and non-GxP impact supporting divestiture of the site. Project completed
in less than 30 days to support sale of the facility on-time and under budget.
o Inspection Team Lead, GlaxoSmithKline FDA Inspection Readiness Effort Rixensart, Belgium
 Developed and executed clinical readout laboratory regulatory assessment plan
including review of all computerized system validation framework and all scientific
procedural controls specific to assays, facilities and equipment.
 Generated assessment report for GSK in advance of an external inspection.
 Developed and delivered inspection readiness training for 24 key scientific managers
and supervisors across the lab in advance of the FDA inspection.
 No observations were issued by US FDA post-training
o Project Manager, Merck Intellution EMS System Validation
 Coordinated factory configuration of an Intellution Environmental Monitoring System
(EMS) with 300 I/O points at Wayne, PA site and 100 I/O points at Oaks, PA site.
 Validated both EMS systems at both locations.
o Senior QA Regulatory Consultant, Bio-Rad Platform Evaluation Berkley, CA
 Provided engineering and compliance evaluation of BioRad platform Version 5
Secured Part 11 software and firmware release.
o Senior Consultant, Mylan Bioniche Acquisition QA and CSV Audit
 Evaluated existing QMS and controlled state of systems and equipment at
compounding facility in Galway, Ireland.

4. JOSEPH V. AULT
(610) 246-2220
jvault314@gmail.com
IVES ENVISION 1999 to 2004
Vice President
Founded and managed IVES ENVISION as a wholly owned subsidiary of Ives Equipment Corporation
based out of King of Prussia, PA. This expanded the parent company revenues to include new and
profitable revenue sources totaling more than $2MM per year. The company provided CSV and QA
support services to biopharmaceutical clients across the US. Capabilities included providing regulatory
consulting support up to complete design, build, commission and validation of hardware platforms with
integrated CSV elements as well as software development and validation.
 Managed up to 21 employees all based in King of Prussia, PA supporting 15 clients across US.
PROCONEX 1993 to 1999
Senior Account Director
C.B. IVES AND CO., INC. 1989 to 1993
Project Coordinator/Applications Engineer
HONEYWELL ACD DISTRIBUTOR 1984 to 1989
Philadelphia Branch Manager
EDUCATION
Drexel University, Philadelphia PA
Chemical Engineering 1986-1992
Fisher Controls Educational Services
Marshalltown, IA and Austin, TX
Advanced Certification, Severe Service Control Valve and Regulator
PROVOX and DeltaV Batch Configuration and Implementation