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8 days old

Senior Operator, Manufacturing

Kelly Services
Princeton, NJ 08544
**Kelly Services** has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a contract temporary opportunity to work as a **Senior Operator, Manufacturing** at a prestigious Fortune 500 company in **Princeton, NJ**



**Contract Length: 1 year**



**Pay rate: $30 - $35/hour**



Job Description



**How will you make an impact?**



Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. The candidate will be a part of a Cell Therapy Manufacturing team and will be responsible for manufacturing of cellular therapy products for clinical applications. He/She will be responsible for following Current Good Manufacturing Practices (cGMPs) to carry out end-to-end processing and verification of patient-derived clinical cellular therapy products. These functions may include but are not limited to activities such as processing of blood related products, isolation and propagation of human primary cells, preparation of cell culture media, culture and expansion of cells in closed systems.



**What will you do?**



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.



Acts as On-The-Job-Trainer for a variety of job functions



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



Execute validation protocols with minimal supervision or direction



Participate in cross-functional teams to complete projects



**How will you get here?**



**Education**



High school degree required. Bachelors degree in Biological Sciences, Medical Technology, Applied Health Sciences or closely related field is preferred.



**Experience**



3-5 years of relevant cGMP experience in a manufacturing pharmaceutical/biotech environment or related areas



Experience in aseptic cell culture processing in IOS 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred



Experience in cell therapy manufacturing required



Experience in cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation preferred



Experience in handling, propagation, isolation, activation and cryopreservation of human primary cells including T cells preferred



Strict adherence to SOPs, GMP regulations, FDA guidance and ability to accurately complete associated documentation required



**Knowledge, Skills, Abilities**



Knowledge



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



**Skills**



Mechnical Skills/ Analytical Skills/Method Automation



MS Office



Strong math skills



Strong prioritization skills



Detail oriented



Results driven



**Abilities**



Able to read, write, and communicate in English



Able to understand and carry out instructions



Reliable



Strong communication (written and verbal)



Effectively multi-task



Able to work in an environment of change



Able to work independently and as part of a team



Able to recognize problems developing, not just occurring



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS
Posted: 2020-10-16 Expires: 2020-11-16

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Senior Operator, Manufacturing

Kelly Services
Princeton, NJ 08544

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