Fill Operator I - 3rd Shift

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

20h

About The Position

The Fill Operator I is responsible for duties in controlled filling and ancillary rooms, including setup and operation, sanitization, equipment cleaning, preventive maintenance activities, and airlock and ancillary-room cleaning. The role requires following approved procedures and performing all duties using acceptable aseptic technique. The operator works in filling suites while fully gowned and may work in a confining environment with moderate-to-loud noise and sanitizing agents.

Requirements

High school diploma required.
At least 1 year of experience operating production equipment and/or analytical instrumentation, or 2 years as a Clean Room Operator.
Good oral and written communication skills.
Ability to document process issues clearly and concisely in accordance with cGMPs and SOPs.
Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.
Ability to understand and carry out written, oral, or diagrammed instructions and address problems involving several concrete variables in standardized situations.
Ability to examine problem areas and make recommendations for corrective action.
Ability to comprehend and follow applicable SOPs.
Must be able to lift 15 pounds and stand for long periods.
Must be able to perform frequent bending, twisting, pushing, pulling, and lifting for cleaning duties.

Nice To Haves

Prior aseptic technique training is preferred but not required.

Responsibilities

Maintain curriculum gowning qualifications.
Perform job duties using acceptable aseptic technique.
Set up and operate automated filling and support equipment, including fillers, stoppering units, and cappers.
Complete applicable paperwork and logbook entries for filling rooms in accordance with approved procedures.
Follow written procedures for operation of the fill room.
Clean equipment and the room, including walls and floors, as necessary.
Collect samples and perform fill-weight checks and other quality checks as necessary.
Assist with or perform preventive maintenance tasks on filling equipment, including inspection and cleaning of machine parts, as required.
Refer process issues to the Supervisor or designee.
Inform the supervisor of maintenance and safety issues.
Work overtime on short notice when production requires.
Perform other duties as determined by the supervisor and management.