Celgene Systems Support Specialist, CAR-T in Summit, New Jersey
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.
Summit, New Jersey
Purpose and Scope of Position
The Specialist, Process & Technology is responsible for the development, testing, and support of the site Manufacturing systems (e.g. ERP & MES) to maintain a compliant, effective, and efficient operation that meets or exceeds site goals and objectives.
Required Competencies: Knowledge, Skills, and Abilities
Advanced proficiency in Microsoft Excel
Advanced written and verbal communication skills
Intermediate knowledge of cGMP regulations
Intermediate proficiency in Microsoft Word and Outlook
Basic presentation development and delivery skills
Ability to provide on-call support in case of emergent issues
Ability to interpret / write technical documents
Ability to gown into Grade C and D classified environments
Ability to work as a team
Duties and Responsibilities
Assist in designing, testing, and maintaining the electronic batch record (EBR) MES Recipes and related Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
Collaborate among peers and internal customers to determine system business requirements.
Translate business requirements into a robust data design and configuration which is compliant, efficient, and effective.
Coordinate, execute, and support User Acceptance Testing of ERP changes and MES Recipe releases with peers and internal customers to ensure business requirements are achieved.
Maintain the recipe release process to meet manufacturing requirements and to maintain compliant, efficient, and reliable electronic batch records and supporting data.
Develop and execute change controls and master data change requests for master data and MES Recipe configuration changes.
Develop system technical documentation; including but not limited to, functional specifications and UAT test scripts.
Provide department representation on site projects.
Perform other tasks as assigned.
Provide direct internal customer ERP and MES support to manufacturing, site planning, materials management, warehouse, quality assurance, quality control, global master data management, and IT.
Develop and provide technical training for MES and ERP users.
Maintain an understanding of the site business processes.
Provide periodic on-call support to internal customers for emergent system issues.
Troubleshoot routine and complex problems to support internal customers.
Perform other tasks as assigned.
Education and Experience
Bachelor’s degree in a related field from an accredited college or university required.
3 years relevant work experience required, preferably in a cGMP manufacturing environment.
Previous experience supporting an Emerson Syncade MES and/or Oracle EBS is a plus.
An equivalent combination of education, experience and training may substitute.
- The incumbent will be required to gown to access classified manufacturing areas.
Definitions and Abbreviations
P&T: Process and Technology
EBR: Electronic Batch Record
EBS: Enterprise Business Suite
ERP: Enterprise Resource Planning
cGMP: Current Good Manufacturing Practices
MES: Manufacturing Execution System
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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
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.