CQV Engineer 2

Job Locations US-NC-Holly Springs
Posted Date 1 month ago(6/20/2024 12:33 PM)
Requisition ID
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies


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.

External US

Major Accountabilities:

• 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


Minimum Requirements:

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


Preferred Requirements:

• 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


FDBN 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 identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.


To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.


Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes
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. No X Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes up to 240 minutes
Ability to sit for prolonged periods of time. No X Yes up to 240 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 50 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes
Will work in warm/cold environments. No X Yes up to 100F Range (mechanical spaces)
Will work in outdoor elements such as precipitation and wind. No X Yes
Will work in small and/or enclosed spaces. No X Yes
Will work in heights greater than 4 feet. No X Yes


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