Position 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. Education and Experience • Bachelor’s degree in Engineering, Science, or related field preferred. • 8+ years of relevant experience in a pharma/biotech manufacturing environment. • Previous supervisory or managerial experience, 2+ years preferred. • Proven ability to successfully work in highly regulated commercial pharmaceutical manufacturing environment with compliance to procedurally driven activities. Technical Skills, Knowledge, Core Competencies • 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 the following systems: 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.