Operator I, Compounding (2nd Shift)

Req #: 1900396
Location: Phoenix, Arizona, United States
Job Category: Technical Development
Work Location: 620 N. 51st Avenue 85043
Organization: Manufacturing
Shift: 2nd Shift_USA
Employee Status: Full-time
Job Type: Regular

OPERATOR 1, COMPOUNDING (2nd Shift)
Phoenix, AZ

Purpose and Scope of Position
The Operator I is responsible for executing production activities required to successfully manufacture sterile injectable products. This is accomplished by ensuring equipment, materials, and other resources are in place to meet production demands. The Operator I demonstrates and assures production activities within manufacturing operations are executed following all GMP's. In addition, work will be performed in complete accordance with all SOPs, Specifications, Batch Records, regulatory expectations, and company policies. This position will require overtime, shift work, and flexibility in scheduling of "set" shift hours at times, based on production demands or extraordinary 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.

Working Conditions

• Aseptic Operations: Requires aseptic gowning into a classified manufacturing environment.
• Compounding: PAPR.
• 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.

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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.