Burlington, Massachusetts
12 days ago
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 maintenanceEquipment calibrationUser Requirements SpecificationsChange ControlsCollect, analyze and report dataSupport 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 ImplementationParticipate in, support, and/or lead Risk Assessments, including FMEAsAssist with materials management activities, including shipping, receiving, material restocking, and material transfer.Assist with various facility activities, including site and asset maintenanceAssist with scheduling, operations management, and enforcement of facility regulationsRequired Education: Bachelor’s Degree in engineeringRequired experience:1-3 yrs experience as a technical contributor and/or in project managementExperience with capital projects and budget management, financing, and related activitiesExperience with facility, utilities, equipment, and system (FUSE) qualificationExperience working in a cGMP environment in the Pharmaceutical or Medical Device industry.Benefits

Fulltime Employment with Azzur can offer you:Flexible PTOTraining and Development Opportunities401(k) matchBonus EligibilityMedical BenefitsPaid HolidaysCompany provided laptopWho 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. #LI-AH1

Confirm your E-mail: Send Email