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CQV Specialist II
2 months ago
Position Overview:
Embark on a career with North America's premier Life Science Manufacturing Facility & CDMO
The contributions we make at FUJIFILM Corporation are critical, and we are in search of skilled professionals to enhance our team. Our organization is expanding its facilities, capabilities, and workforce, seeking dedicated individuals who aspire to impact lives positively. Join FUJIFILM and play a pivotal role in producing the next generation of vaccines, therapies, or gene treatments in collaboration with leading biopharmaceutical firms worldwide. We take pride in fostering a culture that ignites your enthusiasm, vigor, and determination - a concept we refer to as Genki.
About the Role:
The CQV Engineer II is responsible for the commissioning and qualification of systems and equipment at our facility. This position collaborates with the CQV team to execute validation tasks, which encompass equipment setup, document review, and dashboard creation. The CQV Engineer II ensures that all systems and equipment adhere to regulatory standards and quality benchmarks.
Key Responsibilities:
- Configure, test, and validate electronic systems to guarantee compliance with regulatory standards (e.g., FDA).
- Interpret piping and instrumentation diagrams (P&IDs) to navigate systems in operational settings.
- Draft and execute validation protocols.
- Coordinate validation activities, including equipment setup and material readiness.
- Create work orders and generate calibration reports within the computerized maintenance management system (CMMS).
- Implement validation protocols for manufacturing and laboratory equipment, as well as process support systems.
- Develop dashboards using Tableau to visualize and analyze CQV data, tracking progress and trends.
- Identify potential risks and escalate issues to senior engineers or management for resolution.
- Establish and maintain equipment and system qualifications and validation protocols.
- Prepare and present report packages for integration into standard operating procedures (SOPs).
- Draft validation master plans for facilities, equipment, and systems.
- Perform additional duties as assigned.
Minimum Qualifications:
A Bachelor's degree in Engineering with a minimum of 2 years of experience in validation processes related to facilities, commissioning, and systems qualifications.
Preferred Qualifications:
A Master's degree in Engineering with no prior experience. Previous exposure to Good Manufacturing Practices (cGMP) or work in a highly regulated sector is advantageous. Familiarity with mammalian cell culture processes is also preferred.
FUJIFILM Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
Physical Requirements:
Physical Demands:
- Ability to work in mechanical/production environments that may require hearing protection.
- Capability to operate a motor vehicle or powered industrial truck.
- Ability to discern audible cues and perform tasks requiring 20/20 corrected vision.
- Ability to conduct activities involving repetitive motions of wrists, hands, and fingers.
- Capacity to lift and move objects weighing up to 50 pounds.
Working Environment:
- May work in varying temperature conditions, including environments up to 100°F.
- Exposure to outdoor elements such as precipitation and wind.
- Ability to work in confined spaces and at heights greater than 4 feet.