OverviewThe Sr. Manager - Facilities Support Operations under the leadership of the Director of Facilities will be responsible for managing the daily maintenance operations including the CCMS/CMMS operation, the work order lifecycle process, the Planning & Scheduling of Maintenance and Calibration activities, and the MRO inventory across multiple facilities. This position will be responsible for the oversight of the maintenance support operations through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a Biotechnology Facility. This position will coordinate with other team members, such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality, and external suppliers to provide a high level of excellence over the maintenance operational activities of FLBT. Also, this position should ensure that departmental milestones and goals are met in accordance with the approved plans and budgets.
External USEssential Functions:- Accountable as a system owner for the management, and operation of the Blue Mountain 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 shutdowns 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 facilities.
- 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 operations staff across the multiple facilities.
- Assist the Director of Facilities 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 Director of Facilities and Human Resources as appropriate.
- All other duties as needed.
Required Skills & Abilities: - 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.
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:
- Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching.
- Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment.
- Regularly lift and move objects weighing up to 50 pounds.
- Climb ladders and stairs of varying heights.
- Work under conditions that may be wet or humid.
- Provide support during off shifts, weekends, and holidays as needed.
- Work in outdoor weather conditions and noisy environments.
- Offer 24/7 support for company activities.
- Maintain mandatory attendance.
Qualifications: - 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; OR
- 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; OR
- 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.
Preferred Qualifications: - 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.
