Job Description - Validation Engineer

Asset Lifecycle and Validation Program



  • Support the design, implementation, and continuous improvement of equipment validation and asset lifecycle programs.

  • Manage qualification and validation activities for facilities, equipment, instruments, systems, and software.


Protocol and Report Development



  • Author and approve validation master plans, protocols (IQ/OQ/PQ), and summary reports.

  • Ensure documentation meets regulatory and internal quality standards.


Execution and Analysis



  • Oversee and execute validation protocols, ensuring accurate data collection and analysis.

  • Interpret results to confirm equipment performance, reliability, and compliance.


Regulatory Compliance



  • Ensure all validation activities comply with FDA, EU, ICH, ISO and relevant standards.


Risk Assessment and Mitigation



  • Conduct and lead risk assessments (e.g., FMEA) to identify potential failure modes and implement mitigation strategies.


Cross-Functional Collaboration



  • Partner with Manufacturing, Facilities, Quality Assurance, IT, Program Management, and external clients to support validation projects and resolve technical issues.


Maintenance of Validated State



  • Manage requalification and revalidation activities following equipment changes, upgrades, or periodic reviews.

  • Maintain validated state documentation and change control records.


Salary Range:  $90,000 - $105,000 depending on qualifications

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