Manager, Market Quality
3 settimane fa
Overview Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000 monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide. We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. The Position The Senior Manager, Metrology and Process Equipment is responsible for coordinating and executing manufacturing equipment and analytical instrument lifecycle management strategies. They will oversee the maintenance, repair, calibration, and safe operation of all equipment used in GMP and GLP activities. This position ensures that equipment is maintained and meets applicable regulatory requirements to support ongoing operations in a fast-paced drug substance manufacturing facility and regulated development laboratories. This role leads the Metrology team by establishing clear direction and priority for operational and strategic project execution and serves as the central point of coordination and communication for cross-functional departments supported by the Metrology team. Responsibilities Develop and oversee execution of strategic plans to grow the equipment maintenance and calibration program at Arrowhead to support new systems and internalize contracted work. Work cross functionally to provide oversight of the transfer of maintenance and calibration responsibility to the maintenance unit from technical experts in Engineering, including establishing maintenance procedures, training plans, spare parts inventories, and service contracts. Partner with quality, internal customers, and supporting departments to improve and optimize maintenance and calibration workflows by developing strategic plans for continuous improvements and oversee plan execution. Provide guidance in the investigation and resolution of calibration and maintenance issues by technical team members within and outside the reporting structure. Lead projects to identify and implement improvements. Provide managerial leadership for the Metrology team including individual development plans, goal setting, performance evaluations, recruitment and retention, and ongoing guidance and feedback for team leaders and technical experts. Organize assignments and resources across the Metrology team to ensure preventative and corrective maintenance is completed on schedule to support business priorities and according to quality and procedural requirements. Responsible for ensuring that the Metrology team has the tools, expertise, and training needed to safely and successfully complete assigned work. Represent business ownership of Arrowhead's regulatory asset management system. Develop a strategic plan for ongoing system issues and enhancements and partner with system administrators in IS&I for implementation. Responsible for the quality and consistency of service records, asset management system data, and equipment files. Develop the annual maintenance budget for the Metrology team and tracks department spend against approved budget throughout the year. Provide oversight and organization for maintenance service contract renewals with support from the Purchasing. Requirements BS degree in engineering / related technical field or equivalent work experience. Advanced knowledge of mechanical and electrical systems. Knowledge of maintenance requirements for manufacturing process equipment such as purified water, clean in place, buffer formulation, and reagent distribution systems. Prior experience with safe work practices such as lockout tagout, hot work permits, and line break procedures. Proficiency with Computerized Maintenance Management Systems, including best practices for asset identification and hierarchies. Prior experience with Blue Mountain Regulatory Asset Manager Prior experience with change controls for equipment and instrument systems in regulated and/or hazardous environments.
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