Operations Engineer I

Engineering Burlington, Massachusetts

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Description

Responsibilities: 
  • Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle. Typical activities include:
  • Equipment validation/qualification including generation and execution of IQ, OQ, and PQ Protocols 
  • Equipment maintenance
  • Equipment calibration
  • User Requirements Specifications
  • Change Controls
  • Collect, analyze and report data
  • Support customer activities related to cleanroom operations, performance, and maintenance.
  • Support environmental and utility monitoring activities.
  • Create and/or revise Standard Operating Procedures (SOPs)
  • Participate in, support, and/or lead Quality Investigations, Root Cause Analysis, and CAPA Implementation
  • Participate in, support, and/or lead Risk Assessments, including FMEAs
  • Assist with materials management activities, including shipping, receiving, material restocking, and material transfer.
  • Assist with various facility activities, including site and asset maintenance
  • Assist with scheduling, operations management, and enforcement of facility regulations
Required Education: 
  • Bachelor’s Degree in engineering
Required experience:
  • 1-3 yrs experience as a technical contributor and/or in project management
  • Experience with capital projects and budget management, financing, and related activities
  • Experience with facility, utilities, equipment, and system (FUSE) qualification
  • Experience working in a cGMP environment in 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 more than 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.
 
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