Fill Operator I - 1st Shift

HIKMA•Bedford, OH

2d•Onsite

About The Position

We are seeking a talented and motivated Fill Operator I. In this role, you will be responsible for the full spectrum of duties in controlled filling and ancillary rooms. This may include but is not limited to: set-up, operation, sanitization, equipment cleaning, PM activities, airlock and ancillary room cleaning, etc.

Requirements

Minimum: High School diploma required.
Minimum: Minimum of one year experience operating production equipment.
Good oral and written communication skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs.
Ability to read and interpret written documents such as safety rules, operating and maintenance instructions and procedure manuals.
Ability to complete required documentation such as production batch records.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.
Ability to examine problem areas and make recommendations for corrective action.
Must be able to comprehend and follow all applicable SOPs.

Nice To Haves

Prior aseptic technique training and working in a clean room environment.

Responsibilities

Regular and predictable onsite attendance and punctuality.
Maintains curriculum gowning qualifications.
Ability to perform all job duties using acceptable aseptic technique.
Ability to perform job duties in one or two of the following areas of manufacturing to include: Parts and production preparation to include use of Parts Washer and Autoclave.
Dispensing of excipients and API in preparation for compounding.
Sets up and operates Compounding/Formulation tanks and equipment.
Sets up & operates automated filling and support equipment such as filler/isolator, stoppering units, and cappers.
Completes applicable paperwork and logbook entries for compounding and filling rooms in accordance with approved procedures.
Follows all written procedures for operation of the compounding and fill rooms.
Performs clean-up of equipment and room, including walls and floor, as necessary.
Collects samples, performs fill weight checks and other quality checks, as necessary.
Assists with or performs preventive maintenance tasks on compounding and filling equipment, such as inspection and cleaning of machine parts, as may be required.
Refers process issues to Supervisor or designee.
Informs supervisor of maintenance and/or safety issues.
Works overtime with short notice when production requires.
Performs all other duties as determined by management personnel.