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.
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
