The posting
Job Description
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.
