Summary:

• Over 20 years of mission-critical software design, development and implementation for financial, pharmaceutical and healthcare industries.
• Proven ability to lead and motivate high performance teams.
• Extensive experience in systems management and networking including administration, management and software/hardware maintenance of medium/large sized networks (Microsoft Windows NT/2000/2003/2008 Server, Active Directory, TCP/IP management, Oracle, SQL Server, Exchange Server, Windows 9x/2000/XP/Vista/Windows 7 clients, routed Internet and WAN connections, Cisco routers).
• Excellent knowledge of mathematics and physics.

January 11 Present Compliance Services Manager, Confidential,Bensalem, PA

• Managing development and deployment of Quality Management System, cSubs software for LiveLink and ComplianceBuilder software ( 21 CFR Part 11)
• Managing and participating in system design meetings, integration testing, regression testing and factory acceptance testing (FAT)
• Developing test plans, procedures and reports
• Providing technical guidance and direction to test team members
• Creating Disaster Recovery plans.
• Creating preventive Maintenance Plans.
• Creating Hardware specifications according to client requirements.
• Creating Software specifications according to client requirements.
• Creating installation checklist of items that must be done on client site.
• Executing on-site product installation.
• Supervising and executing on-site checklists.
• Training on-site peers in the configuration of the product.
• Preparing Backup/Archival/Restore test plans.
• Managing multiple projects, budgets, and schedules
• Providing regulatory guidance to the clients regarding Computer System Validation (CSV),

Quality System Regulations and current Good Manufacturing Practice
(cGMP)

• Managing systems accounts and roles; established and administered network, firewalls, routers and corporate databases security.
• Ensuring that projects are completed on time and within budget
• Assisting Sales & Marketing as technical liaison during presentations
• Developing and delivering training to clients

August 02 December 10 Project Manager/Product Manager, Confidential,Bensalem, PA

• Managed development and deployment of Quality Management System software for LiveLink and ComplianceBuilder software ( 21 CFR Part 11)
• Managed multiple projects, budgets, and schedules
• Ensured that projects are completed on time and within budget
• Assisted Sales & Marketing as technical liaison during presentations
• Developed and delivered training to clients

August 96 August 02 Software Engineer, Project Manager, Design &
Development, Confidential,Hudson, OH

• Managed the design and support of the GMAC Tracking Insurance System. (TrackOne) for over 5,000,000 accounts using VAX Basic as a Front End and VMS indexed and sequential files as a Back End in VMS environment.
• Managed the design of the NEW GMAC Tracking Insurance System using Visual Basic as a Front End and SQL Server as Back End in MS Windows environment.
• Designed and implemented Tracking Insurance System (TrackOhio) for the state of Ohio using Obsydian as a Front End and Sybase as a Back End in MS Windows environment.
• Designed and implemented Patient Tracking System for the Health Industry using Visual Basic as a Front End and MS Access as a Back End in MS Windows environment.
• Programmed and maintained PC Interface to Mainframe.
• Built commercial Web sites with database support using HTML and ASP as a Front End.
• Supervising and mentoring new software engineers.
• Provided technical assistance to data processing staff.

November 92 July 96 Consultant, Confidential,Cleveland, OH

• Developed Visual Basic Projects for employee benefits and HR administration, including defined contributions and defined benefits.
• Assisted clients on their sites with the installation and training.
• Conducted training sessions for users.

July 81 May 92 Software Engineer, Confidential,Russia

• Evaluated a variety of software packages and adapted them for specific customer needs.
• Unified these packages from different suppliers into a single user-friendly software system.
• Completed automation of the cellulose production unit.

MS in Mechanical Engineering

Training:

2004 Writing a Validation Plan, Stelex University, Bensalem, PA
Writing a System Requirements Specification, Stelex University, Bensalem, PA
Designing and Performing a Risk Analysis, Stelex University, Bensalem, PA
Writing a System Design Specification, Stelex University, Bensalem, PA
Writing an IQ/OQ/PQ, Stelex University, Bensalem, PA
Writing a System Retirement Plan , Stelex University, Bensalem, PA
Creating a System Management Plan , Stelex University, Bensalem, PA
Validation of Computer System for 21 CFR Part 11 Compliance, Stelex
University, Bensalem, PA

2003 Introduction to FDA/GxP , Stelex University, Bensalem, PA
Introduction to CSV/SLC , Stelex University, Bensalem, PA

2002 Introduction to the FDA Regulations and CSV, Stelex University. Bensalem, PA
21 CFR Part 11, Stelex University, Bensalem, PA
IT Infrastructure and 21 CFR Part 11, Stelex University, Bensalem, PA

1996 Developer for Obsydian platform, certified by Synon