Celgene Sr GxP Analyst in Bothell, Washington

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The primary focus of the Senior GxP Systems Analyst will be to collaborate, define, develop, deliver and support controlled GMP applications and systems at use in the Juno Therapeutics manufacturing plant in Bothell WA.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 GMP lab applications and systems 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.This role requires drive for success, enthusiasm, excellent collaboration and communication skills, and current technical skills in the areas of responsibility outlined below.Job Description:

  • Collaborate with scientists, instrument vendors, and IT colleagues to plan, test, and implement new systems in a controlled manufacturing environment.

  • Administer GxP applications and systems including testing and deployment of OS images, patches and instrument-specific software.

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

  • Develop standard operating procedures which ensure the integrity of laboratory applications/systems and the data collected on each platform.

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

  • Provide Tier 1-3 IT operational support for GMP QC and Manufacturing lab environments.

Basic Qualifications:

  • Minimum 10 years of hands on IT support experience at a life sciences (biopharmaceutical preferred) organization, with at least 4 years supporting GMP lab applications and systems.

  • Demonstrated experience in testing, installing, configuring and maintaining GMP applications and systems.

  • Significant experience with the administration, configuration, and troubleshooting of PC hardware and Microsoft Windows in an Active Directory environment.

  • Experience with one or more of the following: software testing and deployment, user access review, asset lifecycle management, data integrity and data archival/backup strategies.

  • Excellent collaboration and communication skills, the ability to manage competing priorities and flexibility to shift work load when needed.

  • Proven working knowledge of GAMP 5, 21 CFR part 11, and Computer System Validation

  • Knowledge of laboratory automation technologies such as electronic laboratory notebooks, lab or manufacturing execution systems, LIMS, chromatography systems, scientific data management systems, etc.

Preferred Qualifications:

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

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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.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE