Director/Manager of Facilities

3 weeks ago

Phoenix AZ, United States Joulé Full time

Title: Director/Manager of Facilities & Equipment Location: Phoenix, AZ area Start Date: ASAP Duration: Direct Hire Hours: Mon-Fri; 8am-5pm Degree: - Minimum of a BS degree preferred Experience: - 5+ yrs. experience managing facilities/equipment, calibration, equipment verification, qualification (IQ/OQ/PQ) in a federally regulated environment (FDA, DOD, DOE, FAA, etc) required "MUST HAVES":

  • Experience working in an FDA regulated environment(Could be Pharma, Med Device, etc. Could use someone from aerospace, etc. Other regulated environments but needs to know FDA regulations)
  • Clean room experience
  • CGMP and GDP highly recommended, GMP is good too(they have ISO clean rooms)
  • Plant operations management, and materials management experience, preferably in a biomedical setting required
  • Proven knowledge and experience project management, creating project timelines, resource management and project scope activities preferred
"Nice to Haves":
  • Experience in forecasting, planning and managing to multiple budget lines related to building and equipment maintenance preferred
  • Electrical and HVAC experience or certification preferred
  • Prior experience with being the Safety Officer and maintaining a compliant and safe working environment preferred
Duties/Responsibilities:
  • Leads the activities of facilities and equipment maintenance and utilizes personnel.
  • Coordinates calibration activities according to regulatory requirements and ensures that equipment, facilities, and systems are always calibrated and maintained
  • Actively participates in execution of process and equipment change controls ensuring all aspects and impacts to other processes, documents, systems are not negatively impacted
  • Writes and updates assigned policies, procedures, forms and related documentation, using established document change control processes, providing training in areas where they are the SME
  • Enforce FDA, AATB, and state rules and regulations and enforce PTT policies and procedures at all times
  • Responsible for the Preventative Maintenance program and ensuring all preventative maintenance is performed according to schedule and in accordance with standards and operating manuals
  • Locate, select, and procure equipment, materials, and services required for operations and represent management in purchase negotiations
  • Provides guidance on staffing requirements, and participates in the interview, hire, and training processes of new associates as required
  • Manages all contracted vendors relationships, contracts, performance for the facilities and equipment while ensuring work is completed on-time, on-budget, and within expectations
  • Completes required training and re-training in equipment operation, work and safety procedures no less than once each year
  • Responsible for all aspects of Facilities and Equipment Maintenance and repair functions including Utilities, Capital, Safety Program and Special Projects.
  • Ensures the building, equipment and facilities are operating in a safe manner in support of production schedules and compliant with FDA regulations and AATB standards
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