Validation Engineer

Asset Lifecycle And Validation Program SupportThe 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 qualificationsNo travel required.Education: Bachelors or better in Engineering or related field.Experience: Proven track record of leading complex validation projects in a cGMP environment. In-depth knowledge of FDA, EU, ISO, and ICH regulations and standards. 3 years: Experience in validation disciplines within regulated life sciences (Pharmaceutical, Biologics, Medical Devices, Combination Products).Preferred: Experience with automated systems, cleanroom equipment, and laboratory