Quality Engineer

Pay: $36.28/Hour Duration: 1 year Location: Frederick, MD (Onsite 5 days a week) Responsibilities Provide Quality oversight and guidance for all cGMP Work Orders performed on critical equipment, facility and utilities necessary for commercial and clinical production. Provide Quality oversight and resolution guidance for all alarms generated by our Equipment Monitoring System (EMS) which actively monitors our critical equipment, facility, and utilities necessary for commercial and clinical production. Demonstrate intimate working knowledge of pharmaceutical relevant standards, principles and best practices. Collaborate with project teams and necessary departments (e.g. manufacturing, engineering, product development, quality control, supplier quality, supply chain) in the execution of CQV and CSV, as needed. Track, review and report metric information as necessary. Support Quality Engineering functions as necessary, including oversight of validation activities and quality risk management. Basic Qualifications Master’s Degree OR Bachelor’s Degree and 2+ years’ experience in a pharmaceutical or FDA regulated environment OR AA Degree and 4+ years’ experience in a pharmaceutical or FDA regulated environment OR High School Degree and 5+ years’ experience in a pharmaceutical or FDA regulated environment. Preferred Qualifications Familiarity with cGMP maintenance planning, execution and closure through a Computerized Maintenance Management System. Familiarity with cGMP calibration planning, execution, and closure through CMMS Experience in building management systems (e.g. Siemens Desigo) is a plus. Experience in CMMS (e.g. BMRAM and/or Maximo) is a plus. Must be able to prioritize, manage and follow-up on numerous projects and activities Cell and Gene Therapy experience is a plus #J-18808-Ljbffr