QC Scientist, Equipment Maintenance CAR-T
Other Locations:US- NJ- Summit West
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.Scientist Equipment Maintenance, QC Systems and Services CAR-TSummit, New Jersey
1. Purpose and Scope of Position
The QC Scientist Equipment Maintenance is responsible for calibration and maintenance activities for all Quality Control equipment in support of analytical and microbiology CAR-T QC laboratories. This includes, but is not limited to, interfacing with SMEs, facilities, and vendors to facilitate equipment maintenance activities and the scheduling and performance of routine calibration activities in support QC equipment.
2. Required Competencies: Knowledge, Skills, and Abilities
- Advanced competency with computers and enterprise applications
- Proficient in the use of LIMS, SAP, and BMRAM
- Working knowledge of analytical and microbiology laboratory equipment. For example; Multisizer, Flow cytometer, BSC, BACTEC, etc.
- Working knowledge of Lean Labs
- Ability to work in a collaborative team environment
- Ability to accurately and completely understand, follow, interpret and apply Global
Regulatory and cGMP requirements
- Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- Ability to do basic equipment troubleshooting
- Ability to set priorities for the equipment maintenance group and manage timelines
3. Duties and Responsibilities
Equipment Calibration and maintenance
- Responsible to facilitate calibration and maintenance for all QC lab equipment performed by vendors
- Responsible for the maintenance of equipment calibration and maintenance records in accordance with cGMP requirements and written procedures
- Responsible for the scheduling of equipment calibration and maintenance and to facilitate vendor visits for repairs, maintenance, etc.
- Responsible for the performance of in-house maintenance activities including, but not limited to, incubator cleaning, freezer defrost and cleaning, etc.
- Responsible to perform training to laboratory personnel on the equipment calibration and maintenance processes as applicable
Function as QC equipment owner/SME
· Responsible for QC activities as it relates to equipment change management
- Collaborate with other departments for commissioning and decommissioning equipment
· Assist management with investigations and deviations related to equipment
- Responsible for the maintenance of equipment logs, equipment status, equipment status label labels, etc.
- Perform approvals for relevant equipment activities
QC Equipment Support
- Provide basic and first-line equipment troubleshooting
- Responsible for the maintenance of electronic equipment database
- Run electronic equipment status reports
- Maintain equipment metrics
Performs other tasks as assigned.
4. Education and Experience
- Bachelor's Degree required, preferable in Science
- Advanced Degree preferred
- 5-8 years of relevant work experience, preferable in a regulated environment
- An equivalent combination of education and experience may substitute
5. Working Conditions
- The incumbent will be working in a laboratory setting up to six (6) hours per day
- The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day
- The incumbent will be working with equipment up to six (6) 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.
#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.