Supervisor, Facilities Support Operations
The Facilities Support Operations Supervisor under the supervision of the Associate Director, Facility Engineering will be responsible for maintaining, administering and improving the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of the operation of the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF), as well as the integration of the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). Primary responsibilities include managing the daily maintenance operations including the CCMS/CMMS administration, the work order lifecycle process, the Planning & Scheduling of Maintenance and Calibration activities, and the MRO inventory across multiple facilities. This position with assigned personnel and/or contractors will be responsible for the oversight of the maintenance support operations through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a Pharmaceutical Manufacturing Facility. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBT. Also, this position should ensure that departmental milestones and goals are met in accordance to the approved plans and budgets.
- Accountable for the management, configuration, and administration of the BlueMountain Regulatory Asset Manager (CCMS/CMMS) across multiple facilities.
- 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.
- 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 in order to support their individual department needs related to the CCMS/CMMS.
- Meet with internal customers in order to plan and schedule calibration and maintenance activities for their instrumentation, systems and equipment across multiple facilities.
- Maintain work load 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.
- Ensure departmental cGMP regulations compliance at all times.
- Oversee and provide leadership to the maintenance operations staff across the multiple facilities.
- Assist the Facility Engineering Associate Director and the Executive Leadership Team in establishing strategic directions for the maintenance operations 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 maintenance operations 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 Facility Engineering Director and Human Resources as appropriate.
Required Skills & Abilities:
- Strong leadership qualities and skills.
- Strong knowledge of Bluemountain 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 for a state of the art facility to operate in a highly regulated GMP environment.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, standing, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate portable tools, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
- Have a normal range of vision.
- May be required to lift up to 50 pounds on occasion.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- This position may include On-Call response for Facility issues.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory
- Associate's degree in a maintenance role or related discipline with a minimum of 5 years of overall experience on which at least 2 years must be in a cGMP or other FDA regulated operation; OR
- High school diploma or general education degree (GED) in a maintenance role or related disciple with 10 years of overall experience on which at least 2 years must be in a cGMP or other FDA regulated operation
- Experience in a planning/scheduling role
- Experience implementing Bluemoutain RAM.
Experience working in a biotechnology facility is preferred.