Engineer Career Network

Quality Engineer II - 8,000 Sign On Bonus

Kite Pharma
Frederick, Maryland, United States (on-site)
30+ days ago

Description



Quality Engineer II - 8,000 Sign On Bonus
United States - Maryland - Frederick

For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

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 2+ years of experience in a pharmaceutical or FDA regulated environment OR
  • Bachelor's Degree and 4+ years of experience in a pharmaceutical or FDA regulated environment OR
  • Associate Degree and 5+ years of experience in a pharmaceutical or FDA regulated environment OR
  • High School Degree and 6+ 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!

* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/kitepharmacareers/job/United-States---Maryland---Frederick/Quality-Engineer-II----8-000--Sign-On-Bonus_R0031962-1







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Job Information

  • Job ID: 65946594
  • Workplace Type: On-Site
  • Location:
    Frederick, Maryland, United States
  • Company Name For Job: Kite Pharma
  • Position Title: Quality Engineer II - 8,000 Sign On Bonus
  • Job Function: Industry Research
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