Computer System Validation - Contract Position

Location: West Point, PA
Date Posted: 07-12-2017
Experience with computer system operations and information architectures while working in several different environments supporting FDA-regulated activities such as IT security and governance, system audits, and validation of software applications and documentation for enterprise applications.
  • Ability to identify and recommend process improvement with the software development life cycle (SDLC).
  • Ability to address 21 CFR Part II compliance issues, provide guidance on computer validation requirements of systems
  • Ability to develop User Requirement Specifications for new and legacy equipment.
  • Conduct validation risk assessments for software applications and equipment and make recommendations for remediation as needed.
  • Assist in developing and reviewing artifacts as required for validation, including validation strategies and plans, validation protocols (IQ, OQ and PQ) and SOPs, Project Status Reports and Action Plans.
  • Assist in the creation and execution of validation test scripts and documented test results in accordance with standards using both automated and manual tools.
  •  Serve as a quality consultant providing advice to departments on broader regulatory issues.

  • Familiar with Oracle and SAP  application development in various platforms
  • Office Tools: Microsoft Office Suite 2007 (SharePoint, Word, Project, Visio, PowerPoint, Excel & Access)
  • Familiar with  Programming Languages: C++, JAVA, SQL
  • FDA Regulations: cGMP and Regulated GxP Environments ( 21CFR Parts 11,210,211 and 820), USP 1058
  • Familiar with HIPAA and FISMA Guidelines
  • Computer System Validation (CSV)
  • Methodologies: Software Development Lifecycle (SDLC),  Agile and Waterfall models
  • Audit Internal Control Frameworks: CoBIT and COSO, Sarbanes-Oxley (SOX sections 302 & 404)
  • Electronic Document Management Systems (EDMS): Documentum v 6.x
  • Automated and Manual Testing Tools: TestDirector / WinRunner, QTP and  HP Quality Center v10.0
  • Incident Management: TrackWise, Maximo, PVCS Tracker v5.0
  • Laboratory Information Systems (LIMs):  Sample Manager, HORIZON, Agilent ChemLMS; Chromatography Data Systems (CDS), Electronic Laboratory Notebooks (ELN)
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