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