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.
1. 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
2. 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
· 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
· Ability to execute complex activities both independently and in a team environment.
3. 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
· 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.
4. Education and Experience
· High school diploma or equivalent required.
· >1 year of relevant work experience required in a pharmaceutical environment.
5. 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.
#LI-POSTCelgene 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.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.