Celgene IT Manufacturing Systems Compliance Specialist 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.

Juno Therapeutics is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

The IT Manufacturing Systems Compliance Specialist will be responsible for ensuring quality and promoting efficiency of Manufacturing Execution System projects at Juno. The individual will work to maximize the utility of the system, including definition of business processes, user engagement and training, as well as document administration activities. The individual will also occasionally be called upon to support software release activities, providing coordination around complex projects, while balancing business priorities. The individual will support projects at Juno’s current multi-product clinical facility in Bothell, WA with potential to support future manufacturing capacity in additional locations.

Primary Responsibilities:

  • 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

Required Experience/Education:

  • 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

Preferred Experience and Skills:

  • 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.

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