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