Cellectis
Manager, Facilities
Cellectis, Raleigh, North Carolina, United States, 27601
Job Description
POSITION SUMMARY
The Manager, Facilities is responsible for the control, accountability, and ownership of the Maintenance, Metrology Program and Engineering functions at Cellectis Raleigh. The primary focus of this position is to provide oversight for Maintenance, Metrology and Engineering to ensure systems remain in compliance with GxP industry standards, ensure instrumentation and equipment are in a calibrated state, develop systems and programs to increase equipment uptime and reliability, to maintain as-built drawings of the facility/major equipment, maintaining an audit ready metrology program, and to review, implement and harmonize facility systems to enable a cost effective, safe, efficient and compliant work environment while supporting various site functions.
POSITION RESPONSIBILITIES Manage equipment reliability throughout the entire life cycle of the asset from design and installation through commissioning and operations to the end of its useful life. Oversee the development and execution of the metrology and facilities functions utilizing the computerized maintenance management system (CMMS). Prepare, develop, and/or approve the team's calibration methods and techniques, automated calibration procedures, and calibration test systems. Prepare, develop and approve facility work instructions and preventive maintenance plans. Participate in the development of design and installation specifications along with acceptance testing, inspection criteria, and operability plans. Ensure the reliability and maintainability of newly installed assets to include proper critical spares inventory management. Review completed calibrations, preventive maintenance, and other work performed in CMMS. Work directly with site personnel to implement end user requirements and maintain the traceability and accuracy of all instruments identified as part of the Metrology program utilizing a validated CMMS. Develop and write site calibration Standard Operating Procedures (SOPs), work instructions (WIs), and other appropriate documents as needed in support of the site. Prepare, develop, and/or approve the team's calibration methods and techniques, automated calibration procedures, and calibration test systems. Responsible for change management, CAPA, and deviations for the metrology and reliability programs. Analyze data and records from the CMMS to identify bad actors and develop plans to ensure the most current technology are utilized and cost effective. Engage with site personnel to determine the cause(s) of equipment failures and develop solutions for improving equipment performance, and implement recommended changes. Provide day to day leadership and expertise in reliability engineering activities that evaluate the reliability of equipment, components and processes using engineering methodologies and tools. Aligns people, resources, and methods with the critical objectives for reliability centered maintenance (RCM) - drive preventive and predictive maintenance programs to maximize equipment uptime and lifecycle. Deploy, manage, and improve predictive maintenance program, including Thermography, Vibration Analysis, Ultrasound technologies, etc. Develops capacity for analysis, testing and measurement that produces effective risk-based failure mitigation plans, including root cause failure analysis (RCFA). Utilizes leadership and expertise in the principles of FMEA, RCFA, and RCM to implement and sustain a culture of continuous improvement. Participates with other departments during planning and process improvement activities to ensure timely completion of all operational area's objectives and milestones. Lead and coach teams in problem-solving, best practices and process improvement. Develop equipment standards to eliminate hazards for operators and maintenance personnel required to maintain equipment performance. Assist in responding to site during normal business hours and potentially off-hours and weekends to maintain operations as needed. Assist in the editing and management of Site Engineering Drawings. Responsible for updates to and continuous improvement of the Building Management System Responsible for the maintenance of facility as-built drawings and flow diagrams Responsible for negotiating best deals with relevant contractors and vendors. Strives for national contracts and discounted pricing. Supports Local Maintenance, Facility, Engineering and Metrology projects on an as needed basis. EDUCATION AND EXPERIENCE
Bachelor's degree in Engineering, Science, or related field preferred. 5+ years combination of applicable experience and education in the pharma/biotech space. Previous supervisory or managerial experience preferred. Proven ability to successfully work in highly regulated commercial pharmaceutical manufacturing environment with compliance to procedurally driven activities. Knowledgeable in the following systems: Instrumentation, Controls, Process Improvement Methodologies, Root Cause Analysis (RCA), Pharmaceutical Processes & Utilities. Technical Skills Requirements / Core Competencies
Versed in cGMP facility system requirements and clean room design and maintenance. Possess competent computer skills in systems like Trackwise, AutoCAD, and CMMS (Maximo). Excellent organizational skills. Good verbal and written presentation and communication skills. Strong collaborative skills and ability to work well in a cross-functional, matrixed environment. Analytical and problem-solving skills. Ability to develop working relationships with a wide range of people. Ability to manage a varied and complex workload. Ability to multitask. Good budget management skills. Sound decision-making ability.
POSITION SUMMARY
The Manager, Facilities is responsible for the control, accountability, and ownership of the Maintenance, Metrology Program and Engineering functions at Cellectis Raleigh. The primary focus of this position is to provide oversight for Maintenance, Metrology and Engineering to ensure systems remain in compliance with GxP industry standards, ensure instrumentation and equipment are in a calibrated state, develop systems and programs to increase equipment uptime and reliability, to maintain as-built drawings of the facility/major equipment, maintaining an audit ready metrology program, and to review, implement and harmonize facility systems to enable a cost effective, safe, efficient and compliant work environment while supporting various site functions.
POSITION RESPONSIBILITIES Manage equipment reliability throughout the entire life cycle of the asset from design and installation through commissioning and operations to the end of its useful life. Oversee the development and execution of the metrology and facilities functions utilizing the computerized maintenance management system (CMMS). Prepare, develop, and/or approve the team's calibration methods and techniques, automated calibration procedures, and calibration test systems. Prepare, develop and approve facility work instructions and preventive maintenance plans. Participate in the development of design and installation specifications along with acceptance testing, inspection criteria, and operability plans. Ensure the reliability and maintainability of newly installed assets to include proper critical spares inventory management. Review completed calibrations, preventive maintenance, and other work performed in CMMS. Work directly with site personnel to implement end user requirements and maintain the traceability and accuracy of all instruments identified as part of the Metrology program utilizing a validated CMMS. Develop and write site calibration Standard Operating Procedures (SOPs), work instructions (WIs), and other appropriate documents as needed in support of the site. Prepare, develop, and/or approve the team's calibration methods and techniques, automated calibration procedures, and calibration test systems. Responsible for change management, CAPA, and deviations for the metrology and reliability programs. Analyze data and records from the CMMS to identify bad actors and develop plans to ensure the most current technology are utilized and cost effective. Engage with site personnel to determine the cause(s) of equipment failures and develop solutions for improving equipment performance, and implement recommended changes. Provide day to day leadership and expertise in reliability engineering activities that evaluate the reliability of equipment, components and processes using engineering methodologies and tools. Aligns people, resources, and methods with the critical objectives for reliability centered maintenance (RCM) - drive preventive and predictive maintenance programs to maximize equipment uptime and lifecycle. Deploy, manage, and improve predictive maintenance program, including Thermography, Vibration Analysis, Ultrasound technologies, etc. Develops capacity for analysis, testing and measurement that produces effective risk-based failure mitigation plans, including root cause failure analysis (RCFA). Utilizes leadership and expertise in the principles of FMEA, RCFA, and RCM to implement and sustain a culture of continuous improvement. Participates with other departments during planning and process improvement activities to ensure timely completion of all operational area's objectives and milestones. Lead and coach teams in problem-solving, best practices and process improvement. Develop equipment standards to eliminate hazards for operators and maintenance personnel required to maintain equipment performance. Assist in responding to site during normal business hours and potentially off-hours and weekends to maintain operations as needed. Assist in the editing and management of Site Engineering Drawings. Responsible for updates to and continuous improvement of the Building Management System Responsible for the maintenance of facility as-built drawings and flow diagrams Responsible for negotiating best deals with relevant contractors and vendors. Strives for national contracts and discounted pricing. Supports Local Maintenance, Facility, Engineering and Metrology projects on an as needed basis. EDUCATION AND EXPERIENCE
Bachelor's degree in Engineering, Science, or related field preferred. 5+ years combination of applicable experience and education in the pharma/biotech space. Previous supervisory or managerial experience preferred. Proven ability to successfully work in highly regulated commercial pharmaceutical manufacturing environment with compliance to procedurally driven activities. Knowledgeable in the following systems: Instrumentation, Controls, Process Improvement Methodologies, Root Cause Analysis (RCA), Pharmaceutical Processes & Utilities. Technical Skills Requirements / Core Competencies
Versed in cGMP facility system requirements and clean room design and maintenance. Possess competent computer skills in systems like Trackwise, AutoCAD, and CMMS (Maximo). Excellent organizational skills. Good verbal and written presentation and communication skills. Strong collaborative skills and ability to work well in a cross-functional, matrixed environment. Analytical and problem-solving skills. Ability to develop working relationships with a wide range of people. Ability to manage a varied and complex workload. Ability to multitask. Good budget management skills. Sound decision-making ability.