Celgene Operator 1 (2nd Shift) in Phoenix, Arizona
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.
OPERATOR I, ASEPTIC/COMPOUNDING (2nd SHIFT)
Purpose and Scope of PositionThe Operator I is responsible for executing production activities required to successfullymanufacture sterile injectable products. This is accomplished by ensuring equipment, materials,and other resources are in place to meet production demands. The Operator I demonstrates andassures production activities within manufacturing operations are executed following all GMP’s. Inaddition, work will be performed in complete accordance with all SOPs, Specifications, BatchRecords, regulatory expectations, and company policies. This position will require overtime, shiftwork, and flexibility in scheduling of “set” shift hours at times, based on production demands orextraordinary circumstances.
Required Competencies: Knowledge, Skills, and Abilities
Robust functionality in Microsoft Applications and other computer based systems utilized in the manufacturing department (i.e. MES, HMI’s, etc.).
Demonstrated proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.
Intermediate written and verbal communication skills within the department and with support groups.
Functional job specific proficiency in mathematics.
Practical understanding of specialized manufacturing equipment operational theory used for the manufacturing of sterile injectable products.
Ability to pass a full physical including a respiratory certification with annual monitoring.
Ability to stand up to 8 hrs/day, utilizing controlled movements.
Aptitude to use hand tools in the setup and trouble-shooting of specialized manufacturing equipment.
Ability to execute complex activities both independently and in a team environment.
Duties and Responsibilities
Accomplishes manufacturing activities per detailed procedural guidance with a demonstrated attention to detail.
Performs handling of hazardous materials in compliance with site, industry, local, and federal regulations.
Maintains manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
Executes specialized responsibilities mandated by detailed written procedures, site, industry, local, and federal regulations.
Assures and completes detailed documentation that is a correct and accurate record.
Addresses procedural /documentation errors expeditiously and effectively.
Continuously updates job knowledge by participating in job specialized training requirements.
Participates as a contributing member in CI projects.
Consistently projects a positive attitude and example for other department team members/operators to emulate.
Performs other tasks as assigned.
Education and Experience
High school diploma or equivalent required.
1 year of relevant work experience required in a pharmaceutical environment.
Aseptic Operations: Requires aseptic gowning into a classified manufacturing environment.
The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 8 hours, approximately 5 times per week.
The incumbent may be working around hazardous materials to include chemical agents at least 8 hours per day.
The incumbent may be in a standing position for at least 8 hours per day.
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.