USA - Production Technician
: Job Details :

Description:Onsite role in Millburn, NJProduction TechnicianWed-Saturday shift Executes all activities related to the manufacturing of RLT products. Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Client radiation safety guidelines are adhered to. Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role. Conducts routine and dynamic environmental monitoring as required. Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators using vaporized hydrogen peroxide. Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure. Participates in periodic mandatory overtime to ensure process continuity and completion. Other duties may be assigned, as necessary. Right First Time Batch Record execution. No recurrent deviations. Adherence to Attendance Guidelines and all Safety related procedures No major or critical audit findings pertinent to the Grade A isolators or Grade B/C areas. Manufacturing compliance/adherent to all GDP/GMP principles Aseptic/Cleanroom behavior in accordance with GMP guidelines Flexibility to don clean room garments and personal protective equipment (PPE). Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted. Makeup, jewelry, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas. Ability to lift or carry up to 35 pounds.Education:Associate degree in a STEM Field or Biopharmaceuticaltraining certificate is highly preferred; If the applicantdoes not have a degree, a minimum of 1-year ofexperience in cGMP or aseptic environment isrequired.Languages: Fluent in speaking / writing in EnglishExperience / Professional requirements: Knowledge of cGMP regulations and FDA guidanceapplicable to aseptic manufacturing is highly preferred. Excellent oral and written communication skills. Excellent organizational and time-management abilities Proficient in MS Office applications. Hours per Day 10 Hours per Week 40 Total Hours 2,120.00