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Utilities Maintenance Manager, B100/B200 & NCTM
Category: Other
  • Your pay will be discussed at your interview
  • Essential Functions: Responsible of taking a leadership role in the day to day activities of the Utilities Maintenance Team. Responsible to respond to plant-wide emergencies and manufacturing needs at all times. Responsible for scheduling and evaluating OEM and vendor training for new or existing equipment provided to operators and technicians, and ensure such training is reflected in current SOPs and other procedures (PMs, Calibrations, etc.) as required. Responsible to support utilities equipment IQ/OQ/PQ or any other validation startup activity as required. Responsible to support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable. Be able to handle multiple priorities quickly and efficiently, and delegate tasks to appropriate trades and skill levels. Organize, coordinate and review daily work orders (WO) and Preventive Maintenance (PM) work. Ensure accurate documentation of maintenance activities such as PM, CM and emergency work orders through adherence of cGDPs. Maintain daily communication with production area counterparts to ensure needs are met. Communicate with Contractors, engineers, OEM providers as well as internal equipment owners and operators for successful start-up of the FDBT facility. Work with other engineers and validation contractors in directing and providing oversight of specialized contractors to ensure facility and equipment are delivered and/or maintained as prescribed. Responsible for developing, writing, editing and/or reviewing SOPs, JHAs, HECPs and operations/maintenance procedures for utilities equipment. Assist with writing

Job code: lhw-e0-90670550

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  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
  15 Views, 0 Applications  
Utilities Maintenance Manager, B100/B200 & NCTM
job descriptions, interviewing and hiring the personnel needed to support the maintenance tasks for the facility. Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility, and document out of specification conditions with deviations, CAPAs and Change Controls as appropriate. Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures. Ensure all mandatory training requirements for the utilities maintenance team are met, including annual EHS training, GMP refresher training and any other applicable training. Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications. Communicate concerns related to safe work practices, hostile work environment, or any other type of employee misconduct directly to the Manager, or Human Resources. Maintenance support to other process systems, including but not limited to fermenters, bioreactors, filtration skids, chromatography columns, autoclaves, washers, agitators, etc. may be required. All other duties as may be assigned. Required Skills & Abilities: Strong understanding of plant and clean utilities equipment and applicable requirements with the ability to instruct and guide others on those requirements. Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities. Have a thorough knowledge of utility equipment, using blue prints, equipment manuals, specifications, standard operating procedures, and be able to use proper judgment when taking corrective actions during equipment malfunction. Must be able to develop clear and correct maintenance procedures for technical equipment using the OEM manual and experience and be able to train direct reports in the proper execution of these procedures. Possess or have the ability to gain knowledge of NFPA 70E requirements for safe work practices and be able to guide direct reports and contractors in such requirements. Possess or have the ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements and be able to guide d

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