Manager, Plant Utilities

Position Overview

The Manager Reliability develops implements and sustains the site reliability strategy ensuring process utility and facility equipment
achieves the availability and performance required for Good Manufacturing Practice (GMP) biologics manufacturing. The role leads the site
programs 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 Process
Engineering Quality and Validation to move the site from reactive and time-based maintenance toward proactive condition- and risk-based
practices. Additionally this role builds and leads a high-performing team of reliability engineers and CBM specialists while serving as the
site 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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What youll do:

Develops and owns the site reliability strategy and multi-year roadmap aligning with the site maintenance master plan and ramp-up
objectives 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 competencies
while 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-functional
assessment sessions and maintenance of criticality rankings in the CMMS; partners with Process Engineering and Quality who own
process and product impact determinations and ensures criticality drives maintenance strategy work prioritization and spare parts
stocking
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 into
the work management process
Develops and implements the mechanical integrity program for pressure vessels piping systems pressure relief devices and other
pressure-retaining and safety-critical equipment including inspection and test plans jurisdictional requirements deficiency
management and records retention
Partners with Maintenance Operations and Process Engineering to optimize preventive maintenance content and intervals using
failure history and condition data ensuring every change is supported by trended evidence risk-assessed and implemented through
formal change control
Leads root cause failure analysis for significant repeat and GMP-impacting equipment failures supports maintenance-related
deviations 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 CBM
compliance 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 14224
taxonomy) and meet data integrity expectations
Defines critical spares requirements and reliability-based stocking recommendations from criticality and failure analysis in partnership
with the spare parts program
Provides reliability and maintainability input to capital projects equipment specifications and commissioning and qualification and
ensures 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 reliability
program 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 on
difficult 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 decision
frameworks
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 and
structured root cause analysis
Hands-on knowledge of CBM technologies and the ability to interpret and act on condition data (e.g. vibration spectra thermographic
images lubricant analysis)
Working knowledge of mechanical integrity codes and standards (e.g. ASME Boiler and Pressure Vessel Code ASME B31.3 ASME
BPE NBIC API 510/570/576)
Proficiency in reliability analysis (e.g. Weibull and life data analysis MTBF/MTTR availability modeling) and in translating analysis
into clear recommendations
Knowledge of CGMP requirements for equipment maintenance change control and quality risk management (e.g. ICH Q9(R1)) in a
regulated 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

Bachelors degree in life science engineering (mechanical
chemical etc.) or related field with 4 years of maintenance
reliability or related industry experience; or
Masters 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 developing
people
Experience working in a fast-paced changing and project
driven organization

Preferred Skills

Prior experience establishing a reliability CBM or mechanical
integrity program at a new or ramping facility
Experience with ISO 55000 asset management practices
3 years of experience in pharma/biological and leading others
in 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 and
change 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
minutes)
Ability to sit for prolonged periods of time. No Yes 240 minutes (If yes may specify frequency/duration: up tominutes)
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 committedto 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 ().

Required Experience:

Manager