About The Position

Our Manufacturing Engineering teams are the people that support the manufacture of our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. A part of our Company's Manufacturing Division, Elkton’s Vaccine Organization is seeking a highly motivated individual at Director level to leads Maintenance team including Associate Directors, Maintenance managers, Shift and Utility engineers, and craft personnel (70-90 people) The successful candidate will lead the Engineering team in the End to End Vaccine Production and will serve as leadership team member for the HPV IPT (Integrated Process Team).

Requirements

  • Bachelor's Degree in Engineering (Maintenance, Mechanical, Electrical or similar technical field) or equivalent Military experience in a relevant in Maintenance or Mechanical/Electrical engineering field with at least ten years of experience in military service (US Navy, US Army, US Marine Corps, US Air Force, US Coast Guard) in maintenance or reliability field.
  • Minimum twelve (12) years of supervisory experience with responsibility for maintenance or reliability direct reports (both salaried and hourly).
  • Minimum of (15) years’ experience in relevant Maintenance or Utilities Operations in areas such as Maintenance Supervisor/Manager, Maintenance Planner and Scheduler, Reliability or Maintenance Engineer or Utilities Maintenance and Operations.
  • Experience with GMP compliant calibration and maintenance databases
  • SAP experience related to plant maintenance and spare parts procurement systems
  • Strong planning, scheduling, and time management skills
  • Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
  • Good oral and written communication skills
  • Project management, including change control and equipment qualification
  • Experience in managing equipment turnover packages, creating operating procedures, maintenance job plans and spare parts documentation.
  • Experience in designing and developing a predictive and preventive maintenance program
  • Demonstrated ability to create an engaged workforce using Inclusion as the How.
  • Demonstrated success with Talent Management.

Nice To Haves

  • Experience in introducing reliability engineering starting at the design of facilities and/or equipment.
  • Reliability Engineering for Maintenance experience (RCM, FMEA, Criticality Analysis, PM optimization, RCA, etc.)
  • Asset condition experience using predictive maintenance tools such as vibration analysis, ultrasound, IR, etc.
  • Experience in CMMS implementations or upgrades such as SAP or ProCal.
  • Union environment experience.
  • Working Knowledge of cGMP for pharmaceutical, Sterile, Biologics and/or Vaccine manufacturing.
  • Demonstrated experience of interacting with site, divisional or regulatory audits.
  • Certified Maintenance & Reliability Professional (CMRP) ) and/or Certified Reliability Leader (CRL)

Responsibilities

  • Production Equipment Support
  • Project Management
  • Shutdown Management
  • Financial Management
  • Coaches/mentors direct reports responsible for each area within the Focus Factory
  • Assistance in deviation investigations for maintenance instruments, equipment, and systems.
  • Collaboration with the Technical CoE reliability engineers to conduct periodic RBAM assessments and own area specific reliability actions
  • Collaborates with Automation for troubleshooting equipment
  • Collaborates with equipment vendors
  • Monitors calibration, maintenance, and equipment/utilities operations performance by analyzing completed work orders with an emphasis on reducing reactive work and increasing reliability.
  • Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.
  • Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures.
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