Engineer 2, Validation

Fujifilm • Holly Springs, NC

3d

About The Position

The CQV Engineer 2 supports commissioning and qualification of site equipment and systems. Working with the CQV team, this role carries out validation activities such as equipment setup, dashboard development, and document review. The position ensures equipment and systems comply with regulatory requirements and quality standards.

The role configures, tests, and validates electronic systems; drafts and implements validation protocols; coordinates validation execution; and prepares qualification and validation documentation for facilities, equipment, and systems. It also develops Tableau dashboards to track CQV progress and trends, identifies risks for escalation, and prepares validation report packages and master plans.

Requirements

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

Nice To Haves

• Master’s degree in Engineering; no prior experience is required for this preferred qualification.
• Prior experience with Good Manufacturing Practices (cGMP) or work in another highly regulated industry.
• Prior experience with mammalian cell culture processes.

Responsibilities

• Configure, test, and validate electronic systems to ensure they are qualified and validated in accordance with standards and regulatory requirements, including FDA requirements.
• Read piping and instrumentation diagrams (P&IDs) and conduct field system walkthroughs.
• Draft and implement validation protocols.
• Coordinate validation activities, including equipment setup, material readiness, and work orders.
• Create work orders, generate calibration reports and maintenance plans, and perform other tasks in the computerized maintenance management system (CMMS).
• Execute validation protocols for manufacturing equipment, laboratory and administrative areas, and process support equipment.
• Develop Tableau dashboards to visualize and analyze CQV data and track progress and trends.
• Identify potential risks and escalate them to senior engineers or management for resolution.
• Create, implement, and maintain equipment and system qualification and validation protocols.
• Prepare and present report packages for implementation into standard operating procedures (SOPs).
• Prepare validation master plans for facilities, equipment, and systems.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level