About this role
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