Process Equipment Engineer II

Описание вакансии

At Kite, our mission is to improve the lives of people living with cancer. Patients are at the core of everything we do. Join our thoughtful and passionate team, and together we can continue making a positive impact in the cancer field.

Kite is seeking a highly motivated individual with cell therapy or biologics manufacturing experience to support the site operations for a new commercial Cell Therapy manufacturing facility in Frederick, MD. The Process Equipment Engineer II position is a key technical and equipment role within the Facilities and Engineering organization. This role will provide engineering support to the technical aspects of validation and commercial manufacturing of cell therapy products and work cross functionally with quality, operations, process development, and MSAT. The role is expected to provide technical input for equipment deviation investigations, change controls, CAPA, new technology implementation, technology transfers, process validation, and asset lifecycle.

Responsibilities include, but are not limited to:

• Support process equipment for multi vector cell therapy facility for MSAT, Manufacturing, QC Micro and QC Analytical functions.
• Support equipment operation for multiple platforms supporting cell therapy manufacturing process
• Evolving Subject Matter Expert for cell therapy process equipment.
• Responsible for developing and maintaining Asset Life Cycle Management, equipment records, spare parts lists, maintenance plans and calibration measurement data sheets
• Specify, procure, and install new assets into the facility. Modify facility as needed to support new assets including space planning, and utility planning and manufacturing process.
• Support quality systems application by documenting investigations and identify root cause associated to equipment and determine proper corrective / preventive actions
• Participate in evaluation of new technology and automation for introduction into the Quality Control labs and MFG suites to improve efficiency, reliability and reduce cost
• Work with vendors and corporate to define equipment requirements
• Write and review technical documentation (Engineering Assessment, FMEA, URS, FRS, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process, and cell therapy manufacturing process validation testing)
• Executes change control and change management including cost and change justification
• Run Capital Projects supporting increased infrastructure and capacity
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed
• May manage the day-to-day activities of a team of personnel and/or contractors
• May be required to work off hours as it relates to projects or plant emergencies
• Additional duties as assigned

Basic Qualifications:

• Master’s and 2+ years of Industry experience OR
• Bachelor’s and 4+ years of Industry experience OR
• Associate’s and 4+ years of Industry experience OR
• High School Diploma/GED and 6+ years of Industry experience

Preferred Qualifications:

• Cell therapy experience
• Bachelors of Science Engineering
• Demonstrated knowledge of biopharmaceutical manufacturing, aseptic processing, cell therapy, and process development
• Practical expertise with cGMP manufacturing and regulatory requirements
• In-depth understanding of scientific and engineering principles
• Process validation experience
• Ability to think critically, with demonstrated troubleshooting and problem-solving skills
• Excellent interpersonal, verbal, and written communication skills
• Ability to function efficiently and independently in a fast-paced environment
• Self-motivated and willing to accept temporary responsibilities outside of initial job description

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