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Process Engineer I - 8,000 Sign On

Kite Pharma
California, United States
30+ days ago

Description



Process Engineer I - 8,000 Sign On
United States - California - El Segundo

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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

Job Description

We are seeking a Process Engineer I to support our commercial biotechnology facility in El Segundo. Under minimal supervision, this position's main accountabilities are focused on the front line technical support of the Cell Therapy process. Under general supervision, this position's main accountabilities are focused on the frontline support of manufacturing operations, equipment implementation, APVs, risk assessments, change control, CAPAs and process improvements.

Responsibilities include, but are not limited to:

  • Provides front line technical support for manufacturing of cell therapy products
    • Resolves routine manufacturing's escalations in a timely manner to no impact production
    • Responsible for generating protocols to allow further manufacturing processing
    • Supports escalation/resolution metrics
    • Performs tracking of lots and presents the progress during daily huddle meetings
  • Ensures successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment, process issues
  • Partners with MSAT Team to execute process development studies within commercial facility to further develop a thorough understanding of operating and performance parameters
  • Represents technical Operations in Change Control, CAPA and Deviation meetings
  • In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools
    • Devises and implements CAPAs to address root cause and ensure effectiveness
    • Initiates deviations and Change controls
  • Collaborates with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
  • Implements continuous design/process changes (low to mediun in complexity) that are required by the Business as a result of Change controls, CAPAs, Enhancements.
  • Develops Work Instructions and SOPs to support the Process
  • Point of contact for help and mentoring to business users of the process
  • Leads projects related to process improvements and or equipment
  • Authors batch records of new processes
  • Leads the MPR (batch record) team to ensure revision of the batch records for existing processes are revised in a timely manner
  • Supports Annual Stability and Sterility runs
  • Supports Annual Product Periodic review for CLP and XLP
  • Supports Engineering, Comparability, PPQ runs (Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing)
  • Supports manufacturing through risk assessments (RA) and remediation measures (e.g. RA SME, technical SME, lead RA)
  • Performs or reviews OQ/ PQ/PPQ testing for equipment or process
  • Reviews URS/ OP/PQ protocols
  • Impact Assessor for proposed and upcoming changes in the process/system
  • Supports regulatory inspections and may serve as Process SME
  • Supports Commercial Process and Metrics Monitoring (e.g. data collection, verification)
  • Participates in the implementation of different Projects
  • Participates in internal audit/inspection
  • Identifies additional training or self-help improvement needs and communicates recommendations
  • Requires general supervision from management
  • Additional duties as assigned by Management
  • Other tasks and duties as assigned by Management



Basic Qualifications:

  • MA/MS Degree in Biochemical Engineering or Chemical Engineering
  • Bachelor's Degree in Biochemical Engineering, Chemical Engineering, Biotechnology with 2+ years of experience Or
  • AA Degree with 4+ years of experience in Biochemical Engineering or Chemical Engineering Or
  • High School Degree with 5+ years of experience in Biochemical Engineering or Chemical Engineering



Preferred Qualifications:

  • Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
  • Cell Therapy CAR-T process Knowledge
  • 1+ years of experience with current Good Manufacturing Practice (cGMP) Regulations
  • 1+ years of experience with MES
  • Possesses good communication skills



* 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, and Singapore 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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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---California---El-Segundo/Process-Engineer-I----8-000--Sign-On_R0028646-1





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Job Information

  • Job ID: 63405826
  • Location:
    California, United States
  • Company Name For Job: Kite Pharma
  • Position Title: Process Engineer I - 8,000 Sign On
  • Job Function: Other
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