FUJIFILM Biotechnologies · 17 hours ago
Sr Manager-Facilities Support Operations
College Station, TX
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expFUJIFILM Biotechnologies is a leader in the biotechnology sector, focusing on innovative solutions for healthcare. The Sr. Manager - Facilities Support Operations will oversee daily maintenance operations, manage the CCMS/CMMS system, and ensure compliance with cGMP standards across multiple facilities.
BiotechnologyHealth CareManufacturing
Responsibilities
Accountable as a system owner for the management , and operation of the Blue M ountain Regulatory Asset Manager (CCMS/CMMS ) across multiple facilities
Responsible to work with eQMS (system administrators) when changes, configuration and improvements are required for the Blue Mountain Regulatory Asset Manager (CCMS/CMMS)
Accountable for the daily maintenance operations including work order lifecycle process, Planning & Scheduling activities, and MRO inventory across multiple facilities
Accountable for the maintenance/ calibration events and Bill of materials creation and management
Develop, implement, and maintain the MRO inventory strategy across multiple facilities
Work effectively with other team members and system users on system issues pertaining to the CCMS/CMMS system
Responsible for coordinating facility shutdown s including systems and equipment, to ensure safety, minimize disruptions and maintain compliance with operational compliance
Make recommendations to the site leadership team for possible improvements to the CCMS/CMMS system
Evaluate CCMS/CMMS data to identify MTBF and identify potential improvements including PDMs program, RCM , and RCA methodologies among others
Conduct periodic reviews and reports for the CCMS/CMMS performance and user’s utilization
Work directly with Manufacturing, Validation, Quality Assurance, Metrology, Maintenance, Facilities, and Quality Control to support their individual department needs related to the CCMS/CMMS
Meet with internal customers to plan and schedule calibration and maintenance activities for their instrumentation , systems and equipment across multiple f acilities
Maintain workload balance across the Metrology and Maintenance Departments
Responsible for developing, writing, editing and/or reviewing SOPs for the maintenance operations
Develop, implement, maintain, and monitor departmental KPIs in order ensure a high level of efficiency
Be able to handle multiple priorities quickly and efficiently, and delegate tasks to appropriate trades and skill levels
Always ensure departmental cGMP regulatory compliance
Oversee and provide leadership to the facilities support o perations staff across the multiple facilities
Assist the Director of Facilities and the Executive Leadership Team in establishing strategic directions for the m aintenance o perations resources and activities and setting objectives to maximize the value of the organization
Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities
Maintain a positive, professional, and customer-oriented attitude
Assist with writing job descriptions, interviewing and hiring the personnel needed to support the maintenance operations
Hire, train, develop and evaluate m aintenance o perations staff. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with the Director of Facilities and Human Resources as appropriate
All other duties as needed
Qualification
Required
Bachelor's degree in a maintenance/facilities or related discipline with a minimum of eight (8) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency
Associate's degree in a maintenance/facilities or related discipline with a minimum of ten (10) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency
High school diploma or general education degree (GED) in a maintenance/facilities or related discipline with a minimum of twelve (12) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency
A minimum of five (5) or more years of previous leadership experience
Strong leadership qualities and skills
Strong knowledge of Blue Mountain RAM implementation, Calibration Procedures, and Maintenance Procedures
Knowledge of a wide variety of typical maintenance tasks, including PM, spare parts, work order lifecycle and troubleshooting systemic problems
General principles of engineering, operations and the tools and equipment required to perform many of the daily maintenance tasks
Strong written and verbal communications skills, be self-motivated and possess interpersonal skills
Ability to work quickly and effectively without constant supervision
Ability to supervise skilled personnel in support of the maintenance operations
Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems
Project management skills
Detail oriented and accurate
Ability to coordinate, facilitate and organize resources
Ability to develop strategic relationships and develop employees within the organization
Ability to work effectively under extreme pressure to meet deadlines
Well organized with ability to handle multiple activities simultaneously
Ability to work in a fast paced, state of the art, alternately research and customized manufacturing facility
Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint) as well as use of Computerized Maintenance Management System, CMMS
In-depth knowledge of calibration, maintenance, and documentation requirements for cGMP manufacturing
Experience in Start-Up & Commissioning of cGMP Facility
This role will require a high level of personal organizational skills, experience and drive
The successful candidate must have a vision of a final state, fully organized group to operate in a highly regulated GMP environment
Preferred
Knowledge of Blue Mountain Regulatory Asset Manager CCMS/CMMS
Knowledge of quality management software
Knowledge of bio-processing equipment, clean utilities, and single use technology
Previous experience in a planning/scheduling role
Company
FUJIFILM Biotechnologies
For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.
Founded in 2011Morrisville, North Carolina, USA
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Lars Petersen
President & Chief Executive Officer
Morten Munk
Director - Global Alliance Management
Recent News
Morningstar.com
2025-10-30
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