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.
• 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 qualifications
• 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 department’s 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
Job Type: Contract to Hire-Full Time
Interviews via Zoom Meeting