What youll 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 FLBNs 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
Bachelors degree in life science engineering or related field
with 8 to 10 years of related experience; or
Masters 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) andleading 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
Bachelors degree in life science engineering or related field
with 10 years of related experience; or
Masters 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
610 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
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
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