Engineer , Commissioning Qualification Validation

Engineer 3, Commissioning Qualification Validation

Location:

US-NC-Holly Springs

Posted: 1 day ago (6/18/2026 12:10 PM)

Requisition :

Category:
Validation

Company: FUJIFILM Biotechnologies

The CQV Engineer 3 supports the commissioning and qualification of equipment and systems for the site. This role performs validation activities to include but is not limited to equipment set up, building dashboards, creating work orders, managing protocols, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards while ensuring successful integration of CQV activities into site projects.

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.

Preferred Requirements

• Master’s degree in Engineering with 3 years of experience in validation activities in facilities, commissioning, and systems qualification.
• Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry.
• Prior experience with mammalian cell culture process.

Physical and Work Environment Requirements

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Will work in environment operating a motor vehicle or Powered Industrial Truck.
• Ability to discern audible cues. No X Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

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.