Validation Engineer

Goal is to have a contractor support the QAV AIQ team for at least up to a year or more.

• Provide quality oversight to Analytical instruments and related computers systems validation activities in alignment with the Analytical Instrument Qualification and Computer System Validation lifecycle process.
• Provide quality oversight to ensure implementation of data integrity controls and data lifecycle mapping (including approval of documents establishing equipment specific period review, backup/restore, and audit trail activities) associated with projects.
• Provide technical assessments on change controls, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
• Own execution and implementation phase quality activities for change controls related to projects, while supporting quality FTE pre and post approvals of change controls.
• Use project management skills to drive results and achieve expected timelines and outcomes.
• Represent the QA-Validation team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements.
• Communicate future needs for method validation for applicable systems to internal QA method validation team.

Example projects:
Particle counter replacement
Floor scale replacement/tie-in to PI Historian
Envision plate reader qualification