PROFILE:

• Senior Software Validation Engineer
• 20 years pharmaceutical company experience in software validation, technical writing, document control and training.
• Graduate studies in the FDA Law, cGCP, cGLP, Computer Software Validation.
• Significant experience in Manufacturing, Clinical and Preclinical systems

TECHNICAL SKILLS:

• Adverse Events System
• ARISg
• Articulate
• Ascent Capture
• Capability Maturity Model Integration
• Documentum
• EDMS
• Enterprise Service Bus
• Excel
• EZsubs
• Gamp 5
• Global Safety Case Receipt
• Impact
• Lotus Notes
• Mercury Quality Center
• Confidential Integration Document Architecture
• Oracle
• Paint Shop Pro
• Picasso (Remedy)
• PowerPoint
• SharePoint
• SnagIt
• SQL*
• Sybase
• Visio
• Windows
• Word

• Application Migration Plan
• Change Control
• Code Remediation Plan
• Configuration Management Plan
• Disaster Recovery Plan
• Impact (Risk) Analysis
• Installation Qualification
• Integration Test Plan/Specifications
• Integration Test Results
• Integration Test Summary
• Operational Qualifications
• Operations Manual
• Production Qualification
• System Design Specifications
• System Test Plan
• System Test Summary
• Traceability Matrix
• Training Plan
• UAT Specification
• UAT Results
• UAT Summary
• Validation Plan
• Validation Summary

• Account Administration
• Backup and Restore
• Change Management
• Computer System Validation
• Disaster Recovery
• Emergency Password Management
• Logical Security
• Managing Service Levels
• Minimum Security Requirements
• Patch Deployment
• Physical Security
• Security Incident Reporting
• Systems Library Management
• System Log Management

• Data Remediation
• Migration Plan
• Code Remediation
• Test Summary

EXPERIENCE:

Technical Writer

Confidential, Lancaster, PA

Responsibilities:

• Writes Standard Operating Procedures
• Edits Standard Operating Procedures
• Trains authors in the use of templates

Consultant

Confidential, Raritan, NJ

Responsibilities:

• Wrote Qualification (Test) Plans
• Wrote Qualification (Test) Summaries
• Wrote Compliance (Project) Summaries
• Advised the team on compliance issues

Confidential, New York, New York

Technical Writer

Responsibilities:

• Edited Delivery Handbook
• Guided Project Managers in the documentation of their applications for project funding from the Program Management Office
• Wrote process instructions for applications for project funding

Confidential, Rahway, NJ

Technical Writer

Responsibilities:

• Wrote / edited / managed project wide documentation including
• Design Specifications Test Execution Summary Test Plan
• Trace Matrix Validation Summary
• Reviewed project - wide documentation for gaps in validation execution.
• Wrote / edited

Confidential

Training Materials Writer

Responsibilities:

• Adapted to the web PowerPoint training materials
• Developed an advisory document for the distribution of system documentation (and responsibilities) from a free standing Enterprise Service Bus (ESB) System to the documentation for the various systems using the ESB.

Senior Consultant

Confidential, Raritan, NJ

Responsibilities:

• Wrote / edited / managed project wide documentation including:
• Code Remediation Template Data Remediation Template
• High Level Execution Plan Impact Analysis
• Migration Plan Template Risk Analysis
• Test Summary Template Validation Plan
• Wrote / edited / managed application specific documentation including:
• Application Migration Plan Change Control Management
• Code Remediation Data Remediation
• Coordinated migration schedules among interested parties, i.e., application & technical owners, support & test specialists, database administrators, etc.
• Confirmed the maintenance of validated states through the migration process employing change control, risk analysis, team reviews and migration signoffs.
• Controlled all migration documentation.
• Compiled project-wide meeting minutes.

Validation Engineer

Confidential

Responsibilities:

• Wrote / edited / reviewed project documentation including:
• Risk Analysis System Design Requirements
• System Project Plan System SOP’s
• Trace Matrix User Requirements Specifications
• User Test Scripts Validation Plan

Senior Validation Consultant

Confidential, Raritan, NJ

Responsibilities:

• Wrote/edited SOP’s to ensure Confidential and Confidential & Confidential Operating Companies conformity with requirements of the Sarbanes Oxley Law including:
• Account Management Backup and Restore
• Change Management Minimum Security Requirements
• Logical Security Patch Deployment
• Password Management System Incident Reporting
• System Library Management System Log Management
• Wrote SOP’s to manage the delivery of services from Confidential to the Johnson & Johnson operating companies including:
• Managing Service Levels SLA Structure Maintenance
• PSS Catalog Maintenance Standard SLA Maintenance
• Controlled Auditing Documentation (System Plans, Test Plans, Test Results Work Instructions). Assembled 17 volumes from over 75 e-room folders.
• Inspected Auditing Documentation for accuracy and completeness.
• Inspected Server Conversion Documentation for accuracy and completeness.

Senior Validation Consultant

Confidential, Teaneck, NJ

Responsibilities:

• Wrote / Edited Software Development Life Cycle documents including:
• Disaster Recovery Plan System Test Plan & Scripts
• Installation Qualification Operational Qualification
• Production Qualification System Test Plan & Scripts
• Test Summaries Training Plan
• UAT Plan and Scripts Validation Summary
• Supervised execution of Validation Protocols (IQ OQ, & PQ)
• Wrote / Edited SOP’s including
• Backup and Restore Change Management
• Computer System Validation Disaster Recovery
• Logical Security Physical Security