Onsite role in Millburn, NJ
Production Technician
Sunday-Wednesday Shift
Pay range : -
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 Biopharmaceutical
training certificate is highly preferred; If the applicant
does not have a degree, a minimum of 1-year of
experience in cGMP or aseptic environment is
required.
Languages : Fluent in speaking / writing in English
Experience / Professional requirements :
Knowledge of cGMP regulations and FDA guidance
applicable to aseptic manufacturing is highly preferred.
Excellent oral and written communication skills.
Excellent organizational and time-management abilities
Proficient in MS Office applications.
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