Quality Engineer III

Job Description

Kite is seeking an experienced, collaborative, and self-driven Quality Engineer II with focus on Quality oversight of maintenance activities, and daily operations facilities & engineering support. This position has the responsibility to provide oversight of all maintenance activities performed on GMP systems, and to provide quality review/guidance in GMP Alarm investigation and resolution at our TCF05 Commercial Operation in Urbana, MD. The Quality Engineer II will serve as the Quality Engineering Facilities & Engineering liaison for the site, as well as the liaison with global F&E supporting Quality Engineers.

Responsibilities (include but are not limited to):

• Provide Quality oversight and guidance for all cGMP Work Orders performed in critical equipment, systems and instruments 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, systems, and instruments 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, CSV, as needed.
• Track, review and report metric information as necessary.
• Support site Quality Engineering efforts and perform other duties as assigned.

Basic Qualifications:

• Master’s Degree and 3+ years of experience in a pharmaceutical or FDA regulated environment OR
• Bachelor’s Degree and 5+ years of experience in a pharmaceutical or FDA regulated environment OR
• High School Degree and 9+ years of experience in a pharmaceutical or FDA regulated environment.

Preferred Qualifications:

• Familiarity with cGMP maintenance planning, execution and closure thru a Computerized Maintenance Management System.
• Familiarity with cGMP calibration planning, execution, and closure thru CMMS.
• Experience in building management systems (e.g. Siemens Desigo) is a plus.
• Experience in CMMS (e.g. BMRAM and/or Maximo) is a must.
• Must be able to prioritize, manage and follow-up on numerous projects and activities
• Must exhibit effective written and verbal communication skills
• Excellent technical writing experience in a regulatory environment.
• Must be detail oriented and exhibit a high degree of flexibility and initiative
• Ability to function efficiently in a diverse, fast paced, changing environment.
• Must be able to work independently as well as part of a team.
• Ability to think critically, and utilize troubleshooting and problem solving skills
• Cell and Gene Therapy experience is a plus

Does this sound like you? If so, apply today!