Production Line Operator, Sterile Filler, 2nd shift (Westwood)

Employment Type

: Full-Time

Industry

: Miscellaneous



2nd Shift: 2:00 pm - 10:30 pm
All Production Line Operators are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.


ESSENTIAL FUNCTIONS:

  • Set up equipment/machines aseptically for proper operation, including installation and disassembly of equipment and parts required.
  • Operate clean room machines aseptically and efficiently (Kalix ointment tube filler, Chase-Logeman bottle filler)
  • Prepare filter wetting solution and bubble point test Hydrophilic and Hydrophobic filters for manufacturing
  • Prepare, weigh and package raw materials (powder) for contract sterilization
  • Make Isopropyl Alcohol 70%, Veshpene and LpH as disinfectants used in Aseptic Manufacturing
  • Must disinfect, deliver and stock gowning components to the gowning room
  • Maintain aseptic gowning qualification
  • Follow aseptic gowning procedures.
  • Perform reconciliations of components, drug products, and associated materials as per defined procedures.
  • Dispose of waste after filling process is finish: Weighing, recording and attaching data or records to Batch Record
  • Set up/preparation/cleaning and autoclaving components used in aseptic manufacturing operations. (Some lifting required, up to 55-60 lbs.) Any object greater than 60 pounds, not to exceed 100 lbs. must require the use of a buddy system. This system requires two employees to lift the object. No employee can lift any object greater than 60 lbs. by themselves.
  • Some Saturdays and Sunday (Overtime) will be required to work by the company based on the departments schedule.
  • Must assume any position required within the department for coverage.
  • Cleaning and sanitization of the aseptic production areas, including filling room sanitization between runs.
  • Must document sanitization activities in log books, forms etc. in a legible manner as per cGMP.
  • Must be able to work until all cleaning activities are complete.
  • Must be flexible in adapting to a work schedule that could change as a result in business direction.
  • Must be detail oriented with the ability to work within a team environment or independent if required.

  • ADDITIONAL RESPONSIBILITIES:

    Must coordinate with packaging dept. senior operators to ensure all production activities are performed and production demands are satisfied.

    Qualifications

    QUALIFICATIONS:
    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    EDUCATION AND EXPERIENCE:

  • High School Diploma or GED required; Associates Degree preferred
  • Previous experience in Pharmaceutical Manufacturing required
  • Previous experience in an aseptic environment required - must be able to be gown-certified

  • JOB PREREQUISITES:
  • Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
  • Strong communication skills.
  • The ability to manage multiple operations, simultaneously during routine duties.


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