Operations Engineer I

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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