Quality Engineer II - El Segundo, CA

We are seeking a highly motivated individual to join us as Quality Engineer II, at our El Segundo location, supporting primarily GMR&R and supporting Kite network. This position must excel in an environment that embraces teamwork, change, resolution making and flexibility. This role is expected to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills.

Job responsibilities include QE oversight of processes related to cGMP such as Commissioning, Qualification and Validation (CQV), Computer System Configuration Management and Computer System Validation (CSV). The position will ensure compliance with Kite’s corporate procedures and all applicable regulatory guidelines as well as Quality oversight of commissioning and qualification of Kite’s manufacturing site, providing guidance and support to the site validation group tasked with implementation of new equipment and manufacturing suites.

Responsibilities

• Reviews commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under direct or indirect supervision.
• Reviews equipment specifications, manuals, and develops an understanding of how equipment works; tests equipment accurately to meet requirements for intended use.
• Reviews engineering drawings for accuracy and error corrections.
• Reviews implemented protocols, final summary of commissioning and qualification reports
• Interacts with project team to identify CQV needs and work toward results that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices under direct or indirect supervision.
• Quality oversight of site CQV in collaboration with Validation, Engineering and external partners ensuring compliance with company procedures, regulatory guidelines and safety standards
• Lead and/or support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation instruments and practices.
• Reviews the Investigation of Commissioning/Qualification failures reports.
• Ensure process control and validation requirements in accordance with company procedures.
• Apply Statistical methods and process excellence instruments to evaluate qualification data.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments
• Perform other duties as assigned.
  
  

Basic Qualifications

• Master’s and 2 years of Quality Engineering /Scientific Method experience OR
• Bachelor’s and 4 years of Quality Engineering /Scientific Method experience OR
• Associate and 5 years of Quality Engineering /Scientific Method experience OR
• High School Diploma/GED and 6 years of Quality Engineering /Scientific Method experience
  
  

Preferred Qualifications

• Knowledge of Quality Systems and pharmaceutical regulatory requirements (ICH8, ICH Q9, ICH10 GAMP5, 21CFR 11/210/211)
• Clear understanding of cGMPs and pharmaceutical and biopharmaceutical unit operations
• Understands and can apply principles of commissioning and qualification when providing quality review.
• Able to provide critical review of DQ, FAT, SAT, OQ, PQ, and PV documents, SOPs.
• Basic understanding of working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines, standards and safety requirements.
• Ability to read and interpret P&IDs and identify boundaries.
• Proficient with Microsoft Word, Excel, PowerPoint, Visio and Project
• Possesses validation knowledge in the following areas: manufacturing and utility systems, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of various temperature and relative humidity loggers
• Detail oriented. Completes work tasks and documentation with minimal errors.
• Ability to work independently or on a team
• Excellent written and verbal communication skills
• Excellent Critical thinking and Statistical skills
• Ability to function efficiently in a diverse, exciting, changing environment.
  
  

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.