Facilities
Description
The design, specification creation, construction, alteration, maintenance and repair of all GMP Buildings, structures, and grounds. Have direct responsibility and ownership for all GMP Facility areas. The GMP Supervisor is also responsible the generation and maintenance of all plant and process utility systems associated with the GMP Manufacturing Operations (Compressed Gases, RO/DI, WFI, Clean Steam, etc.).
Provide a single point of contact for all Manufacturing issues.Direct and coordinate the day-to-day operation and maintenance of all GMP Utility and GMP related facility systems.Supervise the daily activities of the GMP Maintenance team through mechanics and contractors for 24 hour, seven-day operation.Plan, coordinate, and prepare schedules for predictive and preventative maintenance inspection program as it relates to GMP equipment and Facilities.
Qualifications
Engineering Design and strong analytical aptitude.Knowledge of building and critical systems (HVAC, RO/DI, WFI, Clean Steam, etc.)
Excellent Communication skills and proven team leadership.Ability to handle multiple projects and priority assessments.Knowledge of FDA, EMEA, SOP, cGMP, and other pertinent standards and guidelines, and regulatory compliance regulations.
Education
B.S in Chemical or Mechanical Engineering
5-10 years in a Pharmaceutical, Biotech, or Medical Device Field.