Director/Manager of Facilities & Equipment

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
23 days ago