Senior Manager, Facilities

Role Summary

Senior Manager, Facilities responsible for leading reliability, metrology, and facilities programs in a regulated pharma/biotech manufacturing environment. Oversees CMMS-driven maintenance, calibration, design and installation standards, and continuous improvement initiatives to maximize equipment uptime and lifecycle.

Responsibilities

• Assist in responding to site during normal business hours and potentially off-hours and weekends to maintain operations as needed.
• 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).
• Assist in the editing and management of Site Engineering Drawings.
• 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.
• 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.
• Back up to the Director, Facilities.
• Ensures the development and execution of annual goals and objectives for their team.
• Supports Local Maintenance, Facility, Engineering and Metrology projects on an as needed basis.
• Such other responsibilities and duties as the Company may from time-to-time assign.

Qualifications

• Required: 8+ years of relevant experience in a pharma/biotech manufacturing environment.
• Preferred: Previous supervisory or managerial experience, 2+ years.
• Preferred: Bachelor’s degree in Engineering, Science, or related field.
• Proven ability to work in a highly regulated commercial pharmaceutical manufacturing environment with compliance to procedurally driven activities.

Skills

• Able to establish operational objectives to support functional and site level priorities
• Obtain results through implementation of processes and policies to select methods and techniques
• Versed in cGMP facility system requirements and clean room design and maintenance
• Possess competent computer skills in systems like Trackwise, AutoCAD, and CMMS (Maximo)
• Knowledgeable in instrumentation, controls, process improvement methodologies, root cause analysis (RCA), pharmaceutical processes & utilities
• 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

Education

• Bachelor’s degree in Engineering, Science, or related field preferred