Fill Operator I - 1st Shift

HIKMA•Bedford, OH

2d•Onsite

About The Position

The Filling Operator I will be responsible for the full spectrum of duties in controlled Parts Preparation, Compounding/Formulation, and Filling. This job has no supervisory responsibilities.

Requirements

Minimum: High school diploma or equivalent.
Minimum of 1 (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/or 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.

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, filter and glove testing.
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.