Position Overview
The Associate /Director, Maintenance role, leads the site maintenance organization, with end-to-end accountability for maintenance operations, maintenance systems, reliability, spare parts, and MRO materials management. This role builds and sustains a Good Manufacturing Practice (GMP)compliant, inspection-ready maintenance program that delivers safe, reliable, and available process, utility, and facility equipment in support of large-scale biologics manufacturing. The Director shapes and executes the maintenance component of the site ramp-up strategy, scaling the organization, processes, and systems as the site moves through qualification into routine commercial manufacturing. Serving as the site's senior maintenance leader, this role partners with manufacturing, quality, engineering, validation, supply chain, and EHS to balance equipment availability, compliance, and cost while also fostering a People First culture and building a high-performing team.
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: https://www.fujifilm.com/us/en/about/region/careers
Job Description
What you''ll do:
- Empowers, leads, and develops a high-performing, multi-disciplined team of leaders and technicians through servant leadership while fostering a culture of People First and continuous learning and development through real-time feedback, coaching, mentoring, and succession planning • Ensures team members are strategically placed in positions and on projects where their skills are effectively utilized and challenged while promoting individual growth and organizational productivity • Establishes and governs the site work management process, including work identification, prioritization, planning, scheduling, backlog management, and schedule compliance, coordinating equipment access and maintenance windows with manufacturing • Owns the maintenance systems strategy, including the computerized maintenance management system (CMMS) as the system of record for equipment master data, work orders, preventive maintenance plans, and spare parts ensuring data integrity (ALCOA+) and compliant use of electronic records • Sponsors the site reliability program and ensures equipment criticality assessment, reliability-centered maintenance, condition-based maintenance, mechanical integrity, and root cause failure analysis are deployed and translated into defensible maintenance strategies • Directs the spare parts program, including critical spares identification, a risk-based stocking strategy that accounts for both equipment criticality and inventory value, storeroom controls, and repair and return processes, in partnership with supply chain and procurement • Develops and executes the maintenance ramp-up plan in support of site capacity growth, including organizational design, headcount and hiring plans, shift coverage models, onboarding of newly turned-over equipment into the maintenance program, and readiness criteria for commercial operation • Governs the preventive maintenance program lifecycle, ensuring that maintenance content and interval changes are risk-assessed, supported by trended performance data, and implemented through formal change control • Ensures the maintenance program complies with CGMP requirements through controlled procedures, change control, deviation and CAPA management, and equipment return-to-service controls; represents Maintenance during regulatory inspections, customer audits, and internal audits • Defines and reports maintenance and reliability performance indicators (e.g., schedule/PM compliance, backlog, equipment availability, mean time between failures, deviations) and leads maintenance business reviews with site leadership • Develops and manages the maintenance operating budget, including labor, contracted services, materials, and spare parts inventory value, and contributes to capital planning and lifecycle replacement decisions • Oversees contracted maintenance service providers and OEMs, including scope definition, onboarding, performance management, and documented oversight consistent with GMP and EHS expectations • Champions a strong safety culture and ensures compliance with EHS requirements, including hazardous energy control (lockout/tagout), permit-to-work, and contractor safety • Builds and maintains strong partnerships with external and internal stakeholders (e.g., Manufacturing, Quality, Validation, etc.) for collaboration on maintenance and calibration projects ensuring FLBN's "One Team" approach and delivery of high-quality support • Evaluates team performance, develops and implements measures to improve productivity and engagement, and partners with People & Culture to recruit, retain, and develop talent • Performs other duties, as assigned
Knowledge & Skills
- Demonstrated ability to build a high-performing technical organization through high-quality 1:1s, actionable feedback, individualized development plans, strategic workforce planning, competency frameworks, succession planning, and retention strategies • Ability to effectively lead and coach a 40+ personnel maintenance and calibration team within a matrixed organization • Build trust with cross-functional peers and resolve issues and conflicting priorities through partnership, negotiation, and clear decision frameworks • Excellent communication, both written and oral with the ability to adapt communication style to differing audiences and advise others on difficult matters • Ability to drive core team culture priorities (e.g., safety, GEMBA, leadership principals, cost consciousness) into the ways of working • Comfortable working in a fast-paced, uncertain and shifting environment while managing multiple tasks/projects simultaneously • In-depth knowledge of cGMP requirements applicable to equipment maintenance and computerized systems in biopharmaceutical manufacturing (e.g., 21 CFR 211.67, 21 CFR Part 11, EU GMP) and the ability to defend the maintenance program during inspections • Working knowledge of reliability and asset management methodologies, including criticality analysis, reliability-centered maintenance, FMEA, condition-based maintenance technologies, root cause failure analysis, and ISO 55000 principles • Experience implementing or governing an enterprise CMMS (e.g., SAP PM, Maximo, Blue Mountain), including equipment master data, work management, and materials management • Strong technical knowledge of biopharmaceutical process and utility equipment (e.g., bioreactors, chromatography and filtration skids, CIP/SIP, WFI and clean steam, HVAC, chillers, boilers) • Proven ability to build maintenance programs and organizations in a startup or ramp-up environment, establishing processes, procedures, and controls where they do not yet exist • Applies risk-based decision making (e.g., ICH Q9(R1)) and uses data to prioritize resources, justify program changes, and communicate trade-offs to senior leadership • Strong financial acumen, including budget development, cost control, and spare parts inventory management • Must be flexible to support 24/7 manufacturing facility.
Required Skills
- Bachelor''s degree in life science, engineering, or related field with 8 to 10+ years of related experience; or • Master''s degree in life science, engineering, or related field with 6+ years of experience in a similar role • 4+ years of experience leading and developing leaders (Managers/Supervisors), and leading, and developing people.• Experience working in a changing, project driven organization
- Prior experience using an enterprise CMMS (e.g., SAP PM, Maximo, Blue Mountain) to manage work orders, PM plans, and maintenance records.
Preferred Skills
- Bachelor''s degree in life science, engineering, or related field with 10+ years of related experience; or • Master''s degree in life science, engineering, or related field with 8+ years of experience in a similar role • 6+ years of experience managing, leading, and developing people • 6‐10 years of experience in pharmaceutical/biological manufacturing operations • Experience leading maintenance through a new facility startup, commissioning and qualification, or ramp-up to commercial manufacturing • Prior experience deploying a CMMS, reliability program, or spare parts program within a regulated manufacturing environment.
PHYSICAL REQUIREMENTS PHYSICAL DEMANDS Will work in environment which may necessitate respiratory protection. No Yes May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No Yes Will work in environment operating a motor vehicle or Powered Industrial Truck. No Yes Ability to discern audible cues. No Yes Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No Yes WORKING ENVIRONMENT PHYSICAL DEMANDS Ability to ascend or descend ladders, scaffolding, ramps, etc. No Yes Ability to stand for prolonged periods of time. No Yes 240 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to sit for prolonged periods of time. No Yes 240 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No Yes Ability to operate machinery and/or power tools. No Yes Ability to conduct work that includes moving objects up to X pounds. No Yes If yes, 10 lbs. 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No Yes ENVIRONMENTAL CONDITIONS Will work in warm/cold environments. No Yes Range 40-100 F (If yes, specify approximate temperature ranges.) Will work in outdoor elements such as precipitation and wind. No Yes Will work in small and/or enclosed spaces. No Yes Will work in heights greater than 4 feet. No Yes Template Revised: July
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 (FDBN_PNC@fujifilm.com).