Director/Manager of Facilities & Equipment from Joulé
Phoenix, AZ 85027
About the Job
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
#m3
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
#m3