Operations Engineer

Location: San Diego Cleanrooms On Demand
Department: Azzur Cleanrooms On Demand Burlington LLC

Job Description

Azzur Group is currently seeking a reliable, motivated Operation Engineer to join our growing organization. In this position, you will support Installation, Commissioning, and Validation.
The Operations Engineer is responsible for providing Engineering and Operational support to the installation,  commissioning, validation, operation, and maintenance of the equipment and facilities at Azzur Cleanrooms On Demand (COD) as a full-time employee (40 hrs per week on average).


Responsibilities: 

Provide Engineering and Facility support to the Operations Team, including:

  1. Provide engineering support to existing and new equipment and facility assets throughout their life cycle. Typical activities include:
    1. Equipment validation/qualification including generation and execution of IQ, OQ, PQ Protocols
    2. Equipment maintenance
    3. Equipment calibration
    4. User Requirements Specifications
    5. Change Controls
  2. Collect, analyze and report data
  3. Support Customer Activities related to cleanroom operations, performance, and maintenance.
  4. Support Environmental and Utility Monitoring Activities.
  5. Create and revise Standard Operating Procedures (SOPs)
  6. Participate in, support, and lead Quality Investigations, Root Cause Analysis, and CAPA Implementation
  7. Participate in, support, and lead Risk Assessments, including FMEAs
  8. Assist with materials management activities, including shipping, receiving, material restocking, and material transfer.
  9. Assist with various facility activities, including site and asset maintenance
  10. Assist with scheduling, operations management, and enforcement of facility regulations

Basic qualifications

  • Bachelor’s Degree with a study concentration in a scientific discipline or engineering.

Required experience:

  • 3-5 yrs experience as a technical contributor and in project management.
  • Experience with facilities, Utilities, Equipment, Manufacturing systems, and  system (FUSE) qualification 
  • Experience with capital projects and budget management, financing, and related activities.
  • Experience working in a cGMP environment of the Pharmaceutical or Medical Device industry.

Benefits

Fulltime Employment with Azzur can offer you:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

Who we are:

Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With over 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays a vital role in developing top-quality talent, fostering more significant innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.



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