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Senior Quality Engineer

Company: Kite Pharma
Location: Frederick
Posted on: September 7, 2019

Job Description:

We are seeking a highly motivated individual to join us as a Senior Quality Engineer Specialist (Automation & CSV) in our new commercial cell therapy production center located in Frederick, MD! You will report into the Director Quality Engineering and provide engineering support of commercial manufacturing of final drug product. Job Responsibilities: Provide Quality Engineering oversight for Automation, and Computer System Validation related activities. Represent site in global matrix team towards strategic automation and corporate CSV goals. Site Quality Engineering SME for Kite's strategic automation roadmap implementation. Provide guidance to the QE CSV team and cross functional system owners. Support the change control process for validated automated systems. Support the computer system validation team. Support the computerized system administration team with strategic input. Drive computerized system compliance aspects with Kite's corporate Quality Engineering. Support regulatory inspections and audits. Support vendor qualification and - compliance audits. Track, review and report metric information for use in continuous improvement of areas of responsibility. Leads efforts/teams focused on identifying primary root causes, and implements corrective and preventative actions to ensure minimal errors/issues. Drives and demonstrates compliance with agency regulations/guidance and standard operating procedures regarding computerized system validation, automated system implementation, and risk management. Authors technical investigation reports, including root cause as it relates to Computerized System Validation (CSV) and automated system related tasks. Actively collaborates with external service providers and internal management to ensure compliance with regulations. Uses advanced statistical techniques for data analysis. Uses complex research techniques and methodologies such as six sigma and kaizen to improve QE processes and procedures. Actively recommends and implements improvements to automated processes, and related document templates. Quality Assurance, GMPs, global Health Authority Regulations and Validation practices/principles. Experience with internal and external audit principals. Support other QE functions as necessary. Knowledge & Skills Demonstrates in-depth knowledge of QE principles, concepts, industry practices, and standards Demonstrates excellent verbal, written, and interpersonal communication skills. Demonstrates ability to interact with senior management. Proficiency in concept, deployment and support of computerized systems. Proficiency in process automation across the commercialization of pharmaceutical/biotech products. Strong experience with global automation compliance requirements. Strong knowledge of GMP, GAMP, SOPs and quality systems. Demonstrates in-depth knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial. Demonstrates knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)). Certification by ASQ (Certified Six Sigma Black Belt, Certified Quality Engineer, and Certified Quality Manager) or other industry recognized professional organizations. Education and Experience Minimum of 10 years of process automation and/or Computer System Validation experience in a GMP environment (Drug Substance or Drug Product); management experience a plus. Bachelor's degree in technical discipline (Computer Science/Engineering or similar). ASQ, Black Belt/Green Belt certifications desirable. Working knowledge of regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10). 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. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma . For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.

Keywords: Kite Pharma, Frederick , Senior Quality Engineer, Other , Frederick, Maryland

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