Sr. Engineer 1, Commissioning Qualification and Validation

Position Overview

The Sr CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Job Description

What You'll Do

• Supports site readiness, technical transfer (TT), and ongoing manufacturing by configuring and maintaining compliant trending systems, as directed
• Coordinates with cross-functional teams to deliver projects on time and in full completeness
• Contributes to building and maintaining routine statistical process control methods and multivariate models for process trending and monitoring
• Supports ad hoc statistical analysis, as needed
• Documents process performance and product health through process trending, monitoring, and supporting annual product reviews and manufacturing campaign summary reports
• Supports technical risk assessments for new manufacturing processes from a process analytics perspective
• Serves as on-call for process analytics issues and concerns
• Supports role in Good Manufacturing Practices (GMP) environment
• Provides technical support for root cause analysis (RCA) and process assessments in response to process deviations, as needed
• Assists with close out of deviations, as required
• Supports generation of master batch records (MBRs) and sample plans, as needed
• Assists site data stewardship activities by ensuring data and analyses are easily findable, accessible, interoperable, and reusable to internal and
  external stakeholders
• Supports in informatics and data systems improvement initiatives to improve scalability, manufacturability, reliability, yield and cost
• Supports the curation of critical knowledge related to process analytics systems and multivariate modeling
• Other duties, as assigned

Minimum Requirements:

• Bachelor's degree in Data Science, Biotechnology, or Chemical Engineering with 5 years of related experience

Preferred Requirements:

• Bachelor's degree in Engineering
• 8 years of experience in validation activities in facilities, commissioning, and systems qualifications
• Experience with cGMP or working in another highly regulated industry

Physical and Work Environment Requirements:

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of up to 240 minutes
• Ability to sit for prolonged periods of up to 240 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to conduct work that includes moving objects up to 50 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
• Will work in warm/cold environments up to 100F Range (mechanical spaces)
• Will work in outdoor elements such as precipitation and wind.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

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

EEO Information

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.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).