The Senior Manufacturing Project Lead leads and organizes manufacturing projects and support activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
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
During the Project Phase
Leads operational readiness initiatives as well as site commissioning and qualification effortsManages cost and schedule execution of project delivery items and manufacturing operational projectsSupports organization and development of operational readinessIn Operations:
Leads manufacturing focused projects at the request of leadershipActively participates and collaborates to meet the need and expectations set forth by Factory X initiatives and other cross site projects, as assignedSupports materials management within manufacturingDrives column packing and changeover activities including the generation of documentsLeads manufacturing support items which could include, but not limited to:Manufacturing change controls and corrective and preventive actions (CAPAs)Short flow investigations and alert/action limitsFinite manufacturing schedulesContinuous improvement, escalation, and mitigation of manufacturing issuesCross site or local manufacturing projectsTechnology transfer manufacturing deliverablesAssist in regulatory inspections and auditsPerform other duties as assignedBasic Requirements
High school diploma/GED with 12 years of related experience ORAssociate degree in life sciences or engineering with 10 years of direct experience ORBachelor’s degree in life sciences or engineering with 8 years of direct experience OREquivalent Military experience/training
Preferred Requirements
Previous experience in cGMP manufacturing environmentRelevant experience in CAPEX/ OPEX projects Ability to lead teams, facilitate workshops and effectively communicate project statusExperienced in campaign lifecycle activitiesUnderstanding of manufacturing equipment, operations, and cadence Bioworks or BTEC Capstone cGMP coursework preferredWORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to discern audible cuesAbility to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include wrists, hands and/or fingersAbility to conduct work that includes moving objects up to 10 poundsWill 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 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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