- 194086 - Manufacturing Operator
- NJ-New Jersey
- Up to $25.00 DOE
- 6 mos
- Chipton-Ross is seeking a Manufacturing Operator for an opening in Princeton, NJ.
Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation and timely documentation. Performance of all manufacturing activities in clean room (ISO 7) environment with specialized sterile gowning. Execution of cell manufacturing and cell processing activities in closed systems and maintaining aseptic technique during processing to ensure highest integrity, viability and sterility of cellular product until release. Work as a part of the team to execute all necessary GMP runs for cell manufacturing in an accurate and timely manner. Perform accurate and error-free calculations of cell concentrations, cell and media dilutions and cell viability throughout the entire cell manufacturing process workflow. Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies. Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback. Critical evaluation of processes, including foresight and thinking ahead. Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting. Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly. Perform timely consumption of materials and completion of quality documentation in appropriate systems. Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. · Work to complete documentation of deviations and events in appropriate systems. Participate in cross-functional teams to complete projects.
0-2 years of relevant cGMP experience in a manufacturing pharmaceutical/biotech environment or related areas. Experience in aseptic cell culture processing in ISO 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred. Experience in cell therapy manufacturing preferred. Experience in handling, propagation, isolation, activation and cryopreservation of human primary cells including T cells preferred. Strong written and oral communication skills. Understanding ‘why’ and not just the ‘how’ of processes and practices. Knowledge of cGMP practices required. Knowledge of deviation investigations preferred. Knowledge of cell culture and aseptic techniques strongly preferred. MS Office. Strong math skills. Strong prioritization skills. Detail oriented. Results driven. Effectively multi-task. Able to work independently and as part of a team.
Accredited BS or MS in biological science or engineering discipline.
Equivalent combinations of education, training, and relevant work experience may be considered.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x179 or (800) 927-9318 x179
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.