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
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-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
• 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 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 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
