Packaging Operator - 2nd Shift

Aquestive Therapeutics•Portage, IN

2d•Onsite

About The Position

Under the supervision of the Production Supervisor, this role is responsible for packaging line set-up, changeovers, minor mechanical adjustments, operation, and cleaning of assigned equipment. The Packaging Operator operates packaging line equipment to ensure continuous runs and provides high-volume supplies to packaging lines to support production operations. This role also involves measuring and monitoring product variables and attributes throughout the production run to ensure designated parameters and quality attributes are met, and documenting the results of in-process testing and batch progress according to the Packaging Batch Record at designated times.

Requirements

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, SOP's and procedure manuals.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Good written communication skills, including the ability to write routine reports and correspondence.
Good verbal communication skills, with ability to speak effectively before groups of customers or employees of organization.
Good math skills, with ability to calculate figures and amounts and apply basic algebra and geometry concepts.
Experience with navigating and operating computer/PLC controlled equipment to input and monitor machine settings and performance.
Knowledge of mechanics, computer use, and equipment operational knowledge is required.
Working knowledge of vision systems for product inspection requirements.
Basic computer skills including Microsoft Outlook, Word and Excel.
Must be available for all shifts and daily and/or weekend overtime.

Nice To Haves

Associate's degree (A. A.) or equivalent from two-year college/technical school is preferred.
Five (5) years’ experience in a mechanical field; with a minimum of three 3) years general experience with production and pharmaceutical equipment operation preferred.

Responsibilities

Setup, adjust, operations and changeover of packaging machine.
Starts machine and observes operation to detect malfunctions of machine.
Stops machine and reports malfunction to supervisor.
Analyze mechanical or operational problems and take corrective action.
Tests equipment for quality operation when changeover is completed.
Advises management of recurring equipment malfunctions and corrective actions required by identifying problems in a timely manner, gathering, and analyzing information to develop alternative solutions while understanding the business impact.
Inspects product to ensure that it is packaged according to specifications.
Comply with all Aquestive policies and procedures, FDA, DEA, and OSHA regulations, and other applicable regulations.
Responsible for accurate and timely documentation in GMP environment.
Maintains clean and safe work environment.
Performs required facility cleans per the master cleaning schedule.
Assist with equipment or process validation efforts.
Support Research and Development and Manufacturing Technology trials and/or engineering studies.
Other duties as assigned.