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Senior Manufacturing Engineer II, Manufacturing Execution Systems

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: May 3, 2021

Job Description:

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 (/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this jobJob DescriptionKite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patients own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are seeking a Senior Manufacturing Engineer II (a Senior Manager level individual contributor) to support the configuration and implementation of the Manufacturing Execution System in Kites manufacturing network. The successful candidate will have experience in a regulated cell therapy, biotech, and/or pharmaceutical setting and will have proven competency and expertise installing, deploying, supporting and troubleshooting Manufacturing Execution Systems (MES). The Senior Systems Engineer will work with Kites manufacturing site teams to deliver on outlined objectives. This position can be located at any Kite manufacturing site or Kite headquarters, with preference for location in Santa MonicaJob Responsibilities:+ Creates process maps / models working with manufacturing and engineering disciplines + Creates data flow diagrams documenting interactions with manufacturing systems, such as ERP (Oracle EBS) Manufacturing floor equipment, Automation Systems + Creates MES Basic Functions using process flow maps + Creates 'Test Harness' MBRs / GMBRs to test Basic functions + Authors Basic Function Functional Design Specifications + Designs GMBRs / MBRs, Creates Parameterized Value Lists (PVLs) with harmonization and standardization in mind + Creates SDLC documentation for GMBRs following GMP / GDP guidelines + Creates Equipment Lifecycle flow diagrams and Equipment state diagrams working with a team + Collaboratively defines and configures Master data in Werum PAS X + Collaborates with Manufacturing and Quality teams to Validate MBRs + Creates standard design rules for MBR creation and gains team buy-in + Advises on standard methodologies for library element creation / GMBR creation + Migrates MBRs between different environments, writes standard operating procedures for migrating GMBRs/PVLsBasic Qualifications:+ Masters degree with 6+ years of experience in engineering, process engineering and manufacturing in a biotech/pharma industry OR + Bachelors degree with 8+ years of experience in engineering, process engineering and manufacturing in a biotech/pharma industry Or + High School degree with 12+ years of experience in engineering, process engineering and manufacturing in a biotech/pharma industryPreferred Qualifications:+ Hands on Werum PAS X MBR design knowledge and broad Werum PAS X knowledge desirable. + Non-Werum MES batch record design experience at minimum, is required. + Process Engineering experience in a biotech or pharma setting is required, preferably in Cell Therapy / CAR T domain + Able to Model Manufacturing Process (Lead Process Mapping exercises / Create Process Maps / Process Models) + Able to articulate Manufacturing Process interactions with Manufacturing Systems (such as ERP, Instruments) and document data exchange + Experience with Process Equipment and Process Automation Systems in MES context + Deep Master Batch Record design expertise demonstrated with formal training and experience + Thorough understanding of Master Data in MES Context, ability to define master data while working with a team from manufacturing/ engineering/ materials management/ supply chain + Experience with SAP integration to Werum PAS X preferred (integration to PAS X from other non-Werum platforms also acceptable) + Experience creating MBR library objects that can be validated once, then referenced / reused in several GMBRs is beneficial + Experience writing standards for MBR design is also a plus + Electronic Batch Record / Recipe authoring experience with other MES platforms is acceptable + Experience with OSI Pi Historian a plus 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 . Sign up to follow @KitePharma on Twitter at /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 for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law (eoc.gov/employers/upload/poster/_screen/_reader/_optimized.pdf) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (ol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (ol.gov/ofccp/pdf/pay-transp/_formattedESQA508c.pdf) 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 (/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this job.Change The World With UsEveryone at Kite is grounded by one common goal curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we dont take success for granted. While weve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

Keywords: Gilead Sciences, Inc., Santa Monica , Senior Manufacturing Engineer II, Manufacturing Execution Systems, Other , Santa Monica, California

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