The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and on-time commercial production. This role provides technical expertise to the immediate team and other stakeholders, as needed. Additionally, this role leads a team of Engineers and provides coaching and direction.
Company OverviewFUJIFILM 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: https://www.fujifilm.com/us/en/about/region/careers
What You’ll Do
Leads the Upstream and Downstream drug substance manufacturing validation engineering team, including activities from thaw through bulk fillProvides support and direction on commissioning and qualification by utilizing technical expertiseOversees and manages a team of experienced engineers supporting operations, technology transfers, and projects on time and within budgetDrives project goals and deliverables to ensure the successful completion of the project phase through commercial manufacturingFosters and sustains a people first culture where the team feels valued, respected, and supported through servant leadershipCreates and implements the strategy for process equipment validation lifecycle, such as Validation Master Plan (VMP), in close collaboration with the technical subject matter expert (SME) network and Large-Scale Business Unit counterpartsManages departmental budget, systems, processes, and team schedulesProvides leadership and direction to the site team to define the commissioning and qualification requirements for execution of client’s processesPartners with Client, Process Engineering, Process Sciences, Quality, Manufacturing and Global Engineering on large-scale platform development, technology innovation, scale-up, and manufacturability as part of technology transfers, as neededEnsures that facilities, laboratory equipment, utility systems, and process equipment are maintained in a qualified and validated stateVerifies and enforces that reports are written accurately and timelyEstablishes systems and procedures to enable period review, requalification, analysis, and reportingDelivers effective, engaging, and informative presentations, as neededPresents site validation programs to regulatory and other agencies, as necessaryProvides team support for critical manufacturing investigations and technical oversight of deviations, change controls and corrective and preventive action (CAPA) regarding equipment qualification from Installation and Operational Performance QualificationEnforces and ensures team adheres to company policies Coaches and mentors’ direct reports to foster professional development and growthParticipates in the recruitment process and retention strategies to attract and retain talentAddresses performance gaps, employee concerns, and partners with HR, as needed for resolutionOther duties, as assigned
Minimum Requirements:
Bachelor’s degree in an Engineering discipline with 12 years of experience in a related engineering (e.g., validation) or anothersimilar role2+ years of previous experience managing a teamExperience working in a cGMP manufacturing facility
Preferred Requirements:
Master’s degree in an Engineering discipline with 8 years of experience in a related engineering (e.g., validation) or anothersimilar rolePrior experience working at a Greenfield siteLarge Capex experiencePrior experience collaborating with global teams
Working Conditions & Physical Requirements:
Will work in environment which may necessitate respiratory protection.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.Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.Ability to ascend or descend ladders, scaffolding, ramps, etc.Ability to stand for prolonged periods of time, up to 120 minutesAbility to sit for prolonged periods of time, up to 120 minutesAbility to operate machinery and/or power tools. Ability to conduct activities using repetitive motions that include writs, hands and/or fingersAbility to conduct work that includes moving objects up to 50 poundsAbility 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 0-110 FWill 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.*#LI-Onsite
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 InformationFujifilm 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 InformationIf 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 (FDBN_PNC@fujifilm.com).
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