Compounder II, 1st shift

17 hours ago

Lakewood, New Jersey, United States Renaissance LLC Full time
Job Title: Compounder II, 1st ShiftCompany: Renaissance LLC

Renaissance LLC is seeking a highly skilled and experienced Compounder II to join our production team. As a Compounder II, you will be responsible for the execution of bulk product batch processing, inclusive of all process-related and administrative activities, as well as equipment preparation activities.

Responsibilities:
  • Follow manufacturing procedures to process bulk product batches to be made right the first time.
  • Perform compounding functions as deemed necessary by operations management and functions where qualified to perform.
  • Operate processing equipment, and execute manual and automated cleaning, sanitizing, and sterilization of tanks and equipment.
  • Perform integrity testing of filters using automated filter integrity test equipment.
  • Able to follow detailed diagrams and written instructions to assemble or disassemble equipment, configure equipment to be washed, configure equipment to be autoclaved.
  • Show progression in competency in all aspects of the position.
  • Demonstrate aptitude and capability to perform multiple tasks at the same time.
  • Able to successfully pass sterile gowning qualification within a 1-month time limit.
  • Aptitude to perform EM monitoring and testing of grade C and D clean rooms.
  • Utilize knowledge to actively demonstrate process trouble-shooting capabilities whenever possible.
  • Ability to maneuver drums and equipment in excess of 50 lbs and the capability to lift weights up to 50 lbs.
  • Maintain accurate and complete documentation in fulfillment of all duties.
  • Understand and comply with current SOP and GMP requirements relevant to the position.
  • Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions.
  • Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment. Assist supervisors and process manager in all other duties as assigned.
  • Proper use of personal protective equipment at all times is required.
  • Perform routine maintenance on process equipment.
  • Perform area cleaning to maintain compliance using phenolic cleaners and sporicidal agent. A full face respirator or PAPR will be required to be worn for this position.
  • Review MBRs throughout process to assure compliance to good documentation practices.
  • Be available for unscheduled and scheduled overtime throughout the work week and weekend when requested.
Qualifications:
  • Prerequisites: One of the following is required to be considered for the role of a Compounder II: 4+ years of relevant experience + High School Diploma or 0 years of relevant experience + Bachelors Degree.
  • Relevant Experience Considerations: Relevant experience is defined by one or more of the following: Previous experience manufacturing product formulations and operating manufacturing-related equipment (mixing tanks, pumps, homogenizers, etc.). Military leadership, logistics, mechanical experience, and/or training comparable to a manufacturing environment. Trade school or work experience in some construction trades. Microbiology or Chemistry lab experience.
Compensation:

Annual salary range: $53,400 - $74,200

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