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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.