Job Description: Req #: 1900944
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, you will be responsible for ensuring quality and promoting efficiency of Manufacturing Execution System projects at Juno. You will work to maximize the utility of the system, including definition of business processes, user engagement and training, as well as document administration activities. You will also occasionally be called upon to support software release activities, providing coordination around complex projects, while balancing business priorities. You will support projects at Juno's current multi-product clinical facility in Bothell, WA with potential to support future manufacturing capacity in additional locations.
Acts as owner for Manufacturing Systems documentation and release coordination.
Authors SOPs, work instructions and training materials defining MES change management process and Software Development Lifecycle (SDLC)
Creates/approves role-based system training for user groups
Assists with refinement and definition of user and system requirements during upgrades or changes
Improves business processes for system documentation/Software development lifecycle
Cross trains to perform other roles within IT Manufacturing Systems department
Bachelor's degree or equivalent in work experience.
3-5+ years relevant industry experience
Strong communication and collaboration skills.
Experience working within electronic document management systems/quality management systems for regulated industries
Excellent written and verbal skills, ability to clearly organize written requirements is essential
Knowledge of cGMP regulations and FDA guidance applicable to computerized systems, electronic records and signatures.
Experience acting as release analyst, project coordinator or document specialist preferred.
Some Manufacturing Systems experience is preferred
Proven ability to understand business goals and recommend new approaches to effect continual improvements in business objectives.
The ability to manage multiple priorities simultaneously, have a strong drive - orientated on results
Strong analytical skills and ability to provide data based insights and observations
Being an enthusiastic team player with a strong drive to create a positive and fun work environment
Passion for innovative and process improvement
Detail oriented with excellent verbal and written communication skills
Desire to grow and take on increased scope of responsibility
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.