Engineer 2, Validation

About the role

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 including equipment set up, building dashboards, and reading and reviewing documents. The role ensures equipment and systems comply with regulatory requirements and quality standards.

Responsibilities

• Configures, tests, and validates electronic systems to ensure they are properly qualified and validated per standards and regulatory requirements (e.g., FDA)
• Reads piping & instrumentation diagrams (P&IDs) to walk through 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 procedures (SOPs)
• Prepares validation master plans for facilities, equipment, and systems

Requirements

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

Qualifications

• Master’s degree in Engineering
• Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
• Prior experience with mammalian cell culture process