Senior Manager, Facilities

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.