IT Engineering Specialist
IT Engineering Specialist
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$ 107185 - 138710
1 Vacancy
Job Description
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were not finished yet.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Everyone at Kite is grounded by one common goal curing cancer. Every single day we seek to establish a direct line between that purpose and our daytoday work. Would you like to join us in this mission
We are seeking a highly motivated individual to join our team at our TCell Manufacturing facility in Frederick MD as an IT Engineering Specialist.
As an IT Engineering Specialist you will be responsible for the delivery of support on the technology platforms that support Kites operations in our manufacturing site. The IT Business Systems Analyst will collaborate with their business counterparts in deploying new enhancements to manufacturing and quality systems.
This includes configuration customization of existing applications developing proof of concept problem solving & troubleshooting and data management capabilities.
You will be an integral and highly visible part of Kites Site IT team reporting directly to the Site IT head. The Site IT team acts as the face of IT to Kites manufacturing organization. Your efforts will support the delivery and performance of the IT systems ensuring quality and high availability.
Responsibilities of the IT Systems Analyst include but are not limited to:
- Work with BPO and vendor for installation and configuration of QC Lab and Manufacturing applications
- Perform application administrative tasks on Manufacturing and QC Lab application servers as needed
- Work with server and networking team to build and configure application servers for use with the QC Lab and Manufacturing application systems
- Continue to develop an understanding of the business processes and all applicable procedures
- Indepth knowledge of GxP operations as it relates to the FDAs CFR 21 Part 11 requirements as well as Good Documentation Practices (GDPs)
- Install and configure Lab/Manufacturing computer systems in a regulated GMP environment
- Oversee and support managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systems
- Work with vendors tech support teams to resolve application errors as need
- Serve as the System Owner/Manager and perform administrative tasks on QC/Manufacturing instruments/systems such as user additions removal and method/assay updates
- Partner with local QA/QE to evaluate and test new upgrades/patches to Operating Systems/applications and write install instruction for Lab/MFG managed services support personnel
- Participate in process reengineering workshops with business and IT stakeholders
- Perform impact assessment on changing product capabilities including impact to integrated (boundary) systems
- Respond to IT support requests to address operational issues with enterprise and quality applications
- Meet with internal clients and stakeholders to diagnose software and middleware issues
- Align with other manufacturing sites and corporate IT to ensure global consistency
- Review/develop SOPs related to administration and installation of applications used in the lab/manufacturing environments
- Work with QC and Manufacturing to fulfil audit requests for all instruments/systems
- Review audit trails with QC and Manufacturing to ensure data integrity and compliance
- Identify/participate in data integrity solutions to ensure FDA compliance for all GxP devices and systems
Basic Qualifications:
- MA/MS degree with 1 years of Operations and/or Manufacturing IT experience OR
- BA/BS degree with 3 years of Operations and/or Manufacturing IT experienceOR
- High School Degree with 6 years of Operations and/or Manufacturing IT experience
Preferred Qualifications:
- BS degree in Information Technology Computer Science or relevant field
- Proven work experience (3 years) in IT supporting business operations
- Experience in a strongly regulated GxP environment preferably pharmaceuticals
- Good understanding and knowledge of computer systems mobile devices networks and other technology products
- Ability to diagnose and troubleshoot basic technical issues
- Familiarity with remote desktop applications and help desk software
- Excellent problemsolving and communication skills
- Ability to troubleshoot complex software issues and provide stepbystep technical help both written and verbal
- Good time management skills interpersonal skills and the ability to think critically
- Resilient with the ability to perform in an ambiguous environment and under pressure
- Versatile with the ability to deliver against strongly regulated requirements
- Consistent excellence in both planning and execution
For additional benefits information visit:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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. NOTICE: EMPLOYEE POLYGRAPH PROTECTION 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. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm 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 systems 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 jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Unclear Seniority
Employment Type
Full-Time
