CQV Engineer

Position Overview

The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.

• 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
• Coordinates the execution of 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 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 potential risks and escalates to senior engineers or management for resolution
• Creates, implements, and maintains equipment and system qualifications and validation protocols
• Prepares and presents report packages for implementation into standard operating procedure (SOPs)
• Prepares validation master plans for facilities, equipment, and systems
• Other duties, as assigned

• Bachelor's degree in Engineering with 2 years of experience in validation activities in facilities, commissioning, and systems qualifications

• Master's degree in Engineering with no prior experience
• Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
• Prior experience with mammalian cell culture process

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().