Job Summary: Under the supervision of the Production Supervisor, is responsible for packaging line set-up, changeovers, minor mechanical adjustments, operation and cleaning of assigned equipment. Operates packaging line equipment to ensure continuous runs; provides high volume supplies to packaging lines to support production operations. Measures and monitors product variables and attributes throughout production run to ensure designated parameters and quality attributes are met. Documents results of in-process testing and batch progress according to the Packaging Batch Record at designated times. Responsibilities:
- Set up, 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.
- Assist with equipment or process validation efforts.
- Support Research and Development and Manufacturing Technology trials and/or engineering studies.
- Other duties as assigned.
Qualifications:
- 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.
- 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, electro-mechanics, pneumatics, PLC controllers, computer use and equipment operational knowledge is required.
- Experience with Class IV lasers for printing application is preferred.
- Working knowledge of vision systems for product inspection required.
- Basic computer skills including Microsoft Outlook, Word and Excel.
- The employee must occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- Must be available for all shifts and daily and/or weekend overtime.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.