Fill Operator I - 3rd Shift

HIKMA•Cherry Hill, NJ

2d•Onsite

About The Position

The Fill Operator I performs duties in controlled filling and ancillary rooms, including setup, operation, sanitization, equipment cleaning, preventive maintenance activities, and cleaning of airlocks and ancillary rooms. The operator works in filling suites while fully gowned and follows aseptic techniques and approved procedures. The role may require overtime on short notice when production requires.

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 perform arithmetic using whole numbers, common fractions, and decimals.
Ability to follow written, oral, or diagrammed instructions and apply common-sense understanding to standardized situations.
Ability to examine problem areas and recommend corrective action.
Must be able to comprehend and follow applicable SOPs.
Must be able to lift 15 pounds and stand for long periods.
Cleaning duties require frequent bending, twisting, pushing, pulling, and lifting.

Nice To Haves

Prior aseptic technique training is preferred but not required.

Responsibilities

Maintains curriculum gowning qualifications.
Performs job duties using acceptable aseptic technique.
Sets up and operates automated filling and support equipment, including fillers, stoppering units, and cappers.
Completes applicable paperwork and logbook entries for filling rooms in accordance with approved procedures.
Follows written procedures for operation of the fill room.
Cleans equipment and rooms, including walls and floors, as necessary.
Collects samples and performs fill-weight checks and other quality checks as necessary.
Assists with or performs preventive maintenance tasks on filling equipment, including inspection and cleaning of machine parts as required.
Refers process issues to the Supervisor or designee.
Informs the supervisor of maintenance and safety issues.
Works overtime on short notice when production requires.
Performs other duties as determined by the supervisor and management.