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16 days old

Manufacturing Operator

Kelly Services
Princeton, NJ 08544
**Kelly Services** is currently seeking a **Manufacturing Operator** in **Princeton, NJ** to work a contract assignment 6 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities includes:**




+ 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



**How will you get here?**




+ BS or MS in biological science or engineering discipline




+ Equivalent combinations of education, training, and relevant work experience may be considered.




+ 1-2 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**




+ 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

+ Ability to travel up to 20%



**Skill/Experience/Education**



Mandatory Manufacturing Operator, Cell Therapy



**APPLY NOW!**



**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com**




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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2021-01-01 Expires: 2021-02-01

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Manufacturing Operator

Kelly Services
Princeton, NJ 08544

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