Lims Systems Analyst

Celgene Corporation Bothell , WA 98021

Posted 5 days ago

Job Description: Req #: 1900943

Location: Bothell, Washington, United States

Job Category: Information Technology

Work Location: 1522 217th Pl SE 98021

Organization: Information Technology

Employee Status: Full-time

Job Type: Regular

In this role as a LIMS System Analyst, you will be to define, develop, deliver and support GMP e-systems at use in the Juno Therapeutics manufacturing plant in Bothell WA. This role will have a primary emphasis on the Quality based systems such as LIMS but will work effectively with other system analysts to support all e-systems at the Juno manufacturing plant.

Key to this role is a willingness to work at all levels of the organization and enthusiastically participate, own and deliver activities related to the implementation and on-going operational support of innovative solutions that provide for the efficient and compliant manufacturing of Juno Therapeutics products. This position will be located at the Juno manufacturing facility in Bothell WA.

As a LIMS System Analyst, you must have knowledge of QC sample workflow and testing, environmental monitoring, quality release, reporting and process trending.

You must have a drive for success, enthusiasm, excellent collaboration and communication skills, and current technical skills in the areas of responsibility outlined below.

PRIMARY RESPONSIBILITIES

  • Drive collaboration between the Quality, Manufacturing, Supply Chain, Facilities and Tech Transfer departments, developing business justification for new capabilities, capturing and documenting detailed requirements; providing input on design and implementation strategy.

  • Actively participate in all phases of application implementation, including the ownership of key deliverables such as User Requirements Specifications, Function Specification, Design Specifications and test cases.

  • Participate in GMP validation activities including the development and execution of IQ/OQ/PQ testing.

  • Provide technical ownership of LIMS and other e-systems to ensure that the technical design of the system is able to support clinical and commercial operations.

  • Provide technical support of LIMS and other e-systems in their production use.

  • Oversee and/or perform application administration duties for systems such as the laboratory information system (LIMS), building automation system (BAS), computerized maintenance management system (CMMS) and plant scheduling systems.

  • Assist in managing the development and promotion to production of LIMS configuration packages.

  • Assist in managing vendor and contract resources in the implementation of plant based applications.

  • Assist in managins the backlog and lead the continuous improvement effort for LIMS and other e-systems.

  • Represent IT in plant based activities such as Change Control Board, Deviations, CAPA and Audits.

  • Participate in facility operational meetings, ensure facility reporting needs are met.

  • Provide training as required for plant based applications.

  • Provide primary support for application related issues.

  • Assure quality customer service to all customers, promote positive service relationships and contribute to supportive and cooperative work environment

REQUIRED QUALIFICATIONS

  • 5+ years of experience in IT and/or QC at life sciences (biopharmaceutical preferred) organizations supporting plant-based GMP applications.

  • Proven expertise implementing and supporting manufacturing applications such as laboratory information system (LIMS), building automation system (BAS), computerized maintenance management system (CMMS) and plant scheduling systems.

  • Strong understanding of laboratory business processes as well as software development lifecycle.

  • Experience developing in LabWare LIMS basic desired.

  • Experience developing queries and reports using T-SQL desired.

  • Experience developing reports using Crystal Reports desired.

  • Experience involving systems integration.

  • Excellent critical thinking, trouble shooting, and collaborative, written and verbal communication skills are required, as is attention to detail and the ability to work within a multi-tasking environment

  • Demonstrated success working in a high-performing, business results-driven environment.

EDUCATION REQUIREMENTS

Minimum Bachelor's degree in a technology or relevant scientific discipline required

#LI-POST

About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.


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Lims Systems Analyst

Celgene Corporation