Validation Engineer

Job Title

Job Description What You'll Do

• Configures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))
• Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field
• Drafts and implements validation protocols
• Executes validation activities (e.g., equipment set up, material readiness, and work orders)
• Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)
• Executes and manages validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.
• Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trends
• Identifies and assesses risks and escalates to senior engineers or management to develop and implement mitigation strategies
• Develops, implements, and maintains equipment and system qualifications and validation protocols
• Prepares and presents report packages for implementation into standard operating procedures (SOPs)
• Prepares validation master plans for facilities, equipment, and systems
• Provides guidance to junior engineers for drafting and implementing validation studies
• Collaborates cross-functionally to ensure successful integration of CQV activities into projects
• Other duties, as assigned

Minimum Requirements

• Bachelor's degree in Engineering with 5 years of experience in validation activities in facilities, commissioning, and systems qualification
• Prior experience leading teams or projects
• Temperature mapping, Thermal Data Loggers, and pre- and post-calibration procedure experience