SUMMARY

Bringing 25 years of experience to the Information System, Life Science and Pharmaceutical Industry, I am a highly adaptive validation engineer with an extensive senior level computer system validation and compliance background, senior level technical experience, and polished client negotiating skills. I am searching to lead and be a part of a professional, respected, team of individuals who successfully manage client needs and Ensure timely delivery of cost - effective, thoroughly evaluated software products to clients.

TECHNICAL SKILLS

Hardware: HPLC, GC, IR, IBM Compatible PC’s, Hubs, Switches, AT&T Optical Fiber Hardware, DSU/CSU, Network topologies, UPS, Network troubleshooting tools, Scanners, Printers, Modems, Tape Drives. Dell PowerEdge servers, PowerVault storage, Perc array controllers Compaq Proliant servers, Smart Array controllers, EMC SAN

Software: Expert Level 21 CFR Part 11compliance issues, Expert Level GCP, GLP subject matter, Documentation Management Systems (Documentum), Quality Systems (Trackwise), HP Quality Center, Laboratory Management Systems (HP) Data Acquisitions Systems (HP, Empower) Network middleware (Citrix), Microsoft Windows 2000 Server & NT Server 4.0, NT Workstation 4.0, Win95,MS Office, MS BackOffice 6.5, SQL Server 6.0, 6.5 & 7.0, Exchange 5.5, Network backup software

PROFESSIONAL EXPERIENCE

Senior Validation Engineer

Confidential, Horsham, PA

Responsibilities:

• Highly adaptive Validation Engineer committed to ensuring that completed software applications and programs meet end-user requirements.
• Specialize in validating compatibility with supporting systems, networks and hardware.
• Ensure timely delivery of cost-effective, thoroughly evaluated software products to clients.
• Software system design concepts, 21 CFR Part 11 requirements, Multiple platform implementation, Software testing and debugging
• Single Sign On (SSO) application implementation team, Pharmacovigilance SOP consolidation team
• Test plan development and execution
• Identifying /resolving issues at various stages of software development to maximize efficiency and improve client satisfaction.

Confidential, Hackettstown, NJ

Senior Validation Consultant

Responsibilities:

• Responsible for multiple system GMP Validations as it pertains to manufacturing Neurotransmitter Medical devices
• Process Control Assessment
• 21 CFR Part 11 Risk Assessments of PCB controller software specifically
• Full SDLC deliverables

Validation Manager

Confidential, Basking Ridge NJ

Responsibilities:

• Responsible for Validation (and maintaining the validated state) of in-house, highly configurable, 21 CFR Part 11 Compliant, EDC/Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC)Authoring/Review and/or Execution of the full Compliment of SDLC Documentation for each product release including, but not limited to, the following:
• Defect Reporting and Follow-thru
• Reviewing / Approving QC documentation in preparation for Code Iteration and Testing Release
• Appropriate communication with shareholders
• Maintaining Change Control
• Product Development matched strategic business goals
• Software Development progress/status

Senior Validation Scientist

Confidential, Morristown, NJ

Responsibilities:

• Manage 21 CFR Part 11 computer system validation projects for web based clinical trial survey application. (GCP) and CRM application.
• Liaison for IT and QA department
• Interpretation of agency requirements as they pertain to various platforms.
• Integration of GXP compliance strategies as they pertain to HIPAA requirements
• Responsible for complete SDLC documentation development and project timelines
• Able to train peers and leaders in the organization on the key aspects and requirements of GCP compliance

Senior Validation Scientist

Confidential Mahwah, NJ

Responsibilities:

• Analyze and deliver 21 CFR Part 11 requirements for prosthetic design application (GMP)
• Deliver to management formal findings and recommendations for achieving compliance as it pertained to GMP regulations.
• Liaison for IT, application development and QA
• Communicate and deliver project status to all levels of management

Confidential

Project Manager

Responsibilities:

• Developed IT Sarbanes-Oxley compliance internal audit controls, procedures, testing, and reporting documentation based on the Control Objectives for Information and Related Technology (COBIT) process framework.
• Coordinated the IT Sarbanes-Oxley change management, service level agreements, disaster recovery and contingency planning efforts.

Confidential

Senior Technical Liaison PM

Responsibilities:

• Implemented 3rd party proprietary software (Provantis) for installation at BMS Syracuse NY, Evansville IN, and Lawrenceville NJ. (GCP & GLP environments).
• Successfully manage relationship between RCM and Instem for continued staffing partnership.

Confidential, East Hanover, NJ

Senior Validation Specialist

Responsibilities:

• Retrospective Qualification of Trackwise system CSV and validation of overall system internationally. (GMP)
• Develop and author for approval, SOP’s in support of Infrastructure and QA.
• Develop and author complete retrospective SDLC documentation package for Part 11 compliance.
• Liaison for IT and QA department

Confidential, Lafayette, NJ

Project Manager Senior Validation Specialist

Responsibilities:

• Responsible for 2-Million-dollar remediation budget and Integral team member of Part 11 Remediation Project Management Office (PMO).
• Provided strategic direction to IT department as it pertained to a previously unregulated Radiochemistry department. (GLP)
• Conduct supplier audits
• Review and Approval of team developed SDLC deliverables for Part 11

Network Infrastructure Support Team

Confidential, Clinton, NJ

Responsibilities:

• AT&T Certified Fiber Optic Installer. Outside Plant Cable as well as Building cable.
• Design, implement and document global fiber optic infrastructure backbone.
• Completed under budget and ahead of deadline
• Design and implement the addition of Confidential personnel to Brookhaven National Laboratories to primary corporate domain in NJ - Including telecommunication circuitry and workstation reconfiguration
• LAN connectivity to outer buildings over laser, CSU, DSU multiplexed on T1.
• Project Leader for site wide Windows 95 upgrade: approximately 800 workstations.
• Managed 15-person team to accomplish the task under budget and on time.