Senior Validation Engineer
RemoteUnited States
Job Summary
Lead validation test activities, collect and analyze data, and drive timely resolution of deviations for equipment, utilities, facilities, and computerized systems. Plan, write, and execute validation protocols and final reports while coordinating cross-functional teams and vendors to meet project timelines. Mentor junior staff, support audits and regulatory inspections, and oversee the development of specification documentation and computer system validation procedures. Monitor and update the Validation Master Plan to ensure compliance with regulatory guidelines and standard practices. Provide leadership in setting priorities, defining timelines, and tracking projects to ensure team deliverables are met within defined schedules.
Required Qualifications
- 8+ years of relevant technical experience
- minimum 5 + years' hands-on validation experience in a regulated environment
- Bachelor's degree in engineering, life sciences, computer science, or a related technical field
- associate's degree in engineering, life sciences, biology with 8 plus years of technical experience
- Experienced with hardware, software, specifically, Microsoft Windows operating system settings and configuration
- process control systems
- databases
- writing and executing IQ, OQ, PQ or equivalent validation protocols
Desired Qualifications
- Advanced degree in engineering, life sciences, or related discipline
- Experience leading projects or supervising small technical teams
- Experience with computerized system validation, including lifecycle documentation and 21 CFR Part 11 concepts
- Familiarity with commissioning and qualification of utilities and automation systems
- Training in Lean, Six Sigma, or continuous improvement methods
- Strong interpersonal skills and experience working with cross-functional stakeholders
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