Reliability Manager

Position Overview

The Manager, Reliability develops, implements, and sustains the site reliability strategy, ensuring process, utility, and facility equipmentachieves the availability and performance required for Good Manufacturing Practice (GMP) biologics manufacturing. The role leads the siteprograms for equipment criticality, reliability-centered maintenance (RCM), mechanical integrity, and condition-based maintenance (CBM),translating equipment risk into defensible, data-driven maintenance strategies. The Manager partners with Maintenance Operations, ProcessEngineering, Quality, and Validation to move the site from reactive and time-based maintenance toward proactive, condition- and risk-basedpractices. Additionally, this role builds and leads a high-performing team of reliability engineers and CBM specialists while serving as thesite subject matter expert for reliability during audits and inspections

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:

Develops and owns the site reliability strategy and multi-year roadmap, aligning with the site maintenance master plan and ramp-upobjectives while reporting progress and performance to maintenance and site leadership• Leads and develops a high-performing team of engineers and specialists through servant leadership and reliability competencieswhile fostering a People First culture where members feel valued, respected, and supported• Leads the equipment criticality assessment program, including the governing methodology and procedure, cross-functionalassessment sessions, and maintenance of criticality rankings in the CMMS; partners with Process Engineering and Quality, who ownprocess and product impact determinations, and ensures criticality drives maintenance strategy, work prioritization, and spare partsstocking• Leads RCM and failure mode and effects analyses on critical assets to identify functional failures, failure modes, and consequences,and to select the most effective maintenance tasks, ensuring strategies are implemented in the CMMS and in controlled documents• Establishes and scales the CBM program in phases, including technology selection (e.g., vibration analysis, infrared thermography,ultrasound, oil analysis, motor circuit analysis), route design, baseline and alarm limits, data trending, and integration of findings intothe work management process• Develops and implements the mechanical integrity program for pressure vessels, piping systems, pressure relief devices, and otherpressure-retaining and safety-critical equipment, including inspection and test plans, jurisdictional requirements, deficiencymanagement, and records retention• Partners with Maintenance Operations and Process Engineering to optimize preventive maintenance content and intervals usingfailure history and condition data, ensuring every change is supported by trended evidence, risk-assessed, and implemented throughformal change control• Leads root cause failure analysis for significant, repeat, and GMP-impacting equipment failures, supports maintenance-relateddeviations, and verifies the effectiveness of resulting corrective and preventive actions• Defines and monitors reliability indicators (e.g., mean time between failures, mean time to repair, equipment availability, PM and CBMcompliance, reactive versus planned work, repeat failures) and leads elimination of bad-actor equipment• Ensures equipment hierarchy, failure codes, and reliability data in the CMMS are structured to support analysis (e.g., ISO 14224taxonomy) and meet data integrity expectations• Defines critical spares requirements and reliability-based stocking recommendations from criticality and failure analysis in partnershipwith the spare parts program• Provides reliability and maintainability input to capital projects, equipment specifications, and commissioning and qualification, andensures newly turned-over assets receive a criticality ranking and maintenance strategy• Authors and maintains controlled reliability procedures, supports change controls, deviations, and CAPA, and represents the reliabilityprogram during regulatory inspections and internal audits• 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

• Effective communication, both written and oral with ability to adapt communication style to differing audiences and advise others ondifficult matters• Willingness to drive core team culture priorities (e.g., safety, GEMBA, leadership principles, cost consciousness) into the ways of working• Comfortable working in a fast-paced, uncertain and shifting environment while managing multiple tasks/projects• Build trust with cross-functional peers and resolve issues and conflicting priorities through partnership, negotiation, and clear decisionframeworks• Demonstrated ability to hire and develop technical talent to lead a high-performing team• Ability to optimize talent by conducting impactful 1:1s, delivering actionable feedback, and utilizing team health to drive improvement• Strong knowledge of reliability methodologies, including RCM (e.g., SAE JA1011/JA1012), FMEA/FMECA, criticality analysis, andstructured root cause analysis• Hands-on knowledge of CBM technologies and the ability to interpret and act on condition data (e.g., vibration spectra, thermographicimages, lubricant analysis)• Working knowledge of mechanical integrity codes and standards (e.g., ASME Boiler and Pressure Vessel Code, ASME B31.3, ASMEBPE, NBIC, API 510/570/576)• Proficiency in reliability analysis (e.g., Weibull and life data analysis, MTBF/MTTR, availability modeling) and in translating analysisinto clear recommendations• Knowledge of CGMP requirements for equipment maintenance, change control, and quality risk management (e.g., ICH Q9(R1)) in aregulated manufacturing environment• Ability to facilitate cross-functional analysis workshops and influence decisions without direct authority• Must be flexible to support 24/7 manufacturing facility

Required Skills

• Bachelor's degree in life science, engineering (mechanical,chemical, etc.), or related field with 4+ years of maintenance,reliability or related industry experience; or• Master's degree in life science, engineering (mechanical,chemical, etc.), or related field with 2+ years of maintenance,reliability, or related industry experience• 3+ years direct reliability engineering experience (e.g., RCM,CBM, root cause failure analysis)• 3+ years of experience managing, leading, and developingpeople• Experience working in a fast-paced, changing, and projectdriven organization

Preferred Skills

• Prior experience establishing a reliability, CBM, or mechanicalintegrity program at a new or ramping facility• Experience with ISO 55000 asset management practices• 3+ years of experience in pharma/biological and leading othersin a pharma/biological manufacturing facility• Experience with an enterprise CMMS (e.g., SAP PM, Maximo,Blue Mountain), including equipment hierarchy, failure coding,and maintenance plan configuration• Experience with regulatory inspections, investigations andchange managemenent.

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 ([email protected]).