Summary: The Packaging Technician 1 is responsible for producing products and general cleaning and upkeep of facility utilizing various types of processes and equipment all while adhering to Good Documentation Practices (GDPs) and Good Manufacturing Practices (GMPs).

Essential Duties and Responsibilities:

• Employee disassembles and performs cleaning of equipment, facility and packaging rooms.
• Employee prepares cleaning solutions in correct ratio as specified in procedures and follows appropriate steps to conduct cleaning.
• Employee sets up packaging equipment and rooms for production.
• Set-up of room or work area includes staging of packaging materials to be used for a packaging run and transferring materials on pallets and cleaning outer containers.
• Employee operates packaging equipment and monitors the process for product defects during the filling and packaging process.
• Employee is expected to follow all packaging instructions on packaging records and Packaging and Labeling Specifications (P&L).
• Employee monitors and loads bulk and components to equipment during packaging process.
• Employee is required to manually load product to be packaged such as filled bottles and bundles of cartons.
• Employee can increase or decrease the speed of equipment using the HMI.
• Basic knowledge of processes enables employee to perform routine tasks and functions related to packaging.
• Employee has basic knowledge of production goals which enables employee to produce at expected level.
• Employee has ability to track metrics, output and downtime using the appropriate trackers or output sheets/ time and motion sheet. Reports output and communicates issues to Lead.
• During the manufacturing processes, employee inspects quality of the product produced.
• When performing manufacturing activities, employee follows good manufacturing practices including use of required gowning supplies (lab coats, gloves, hair covers, face mask).
• During the manufacturing processes, issues related to product quality are communicated to a Lead or Supervisor.
• Employee follows good documentation practices to ensure that data recorded on any documents is legible, accurate and timely. This includes verification of calculations and accurate times recorded for timed activities.
• Employee is aware of and follows safety policies. Practices safety by using lockout tag out when setting up and cleaning packaging equipment.
• Employee maintains facility and work areas in clean and organized conditions. Cleans the facility and packaging equipment in accordance with established schedules and procedures.
• Employee performs tasks and manufacturing activities as per established procedures.
• May be required to perform other duties as assigned or as needed.

Supervisory Responsibilities: This position has no supervisory responsibilities.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

• High school diploma or general education degree (GED); or 6 months to one year in an FDA regulated Food, Pharmaceutical or Supplement Packaging environment desired; or equivalent combination of relevant experience, training and/or education.
• Experience in a cGMP compliant work environment preferred.

Knowledge, Skills, and Abilities:

• Ability to perform simple setups and changeovers of equipment.
• Basic troubleshooting of the equipment.
• Communicates cross functionally with other departments to ensure that adequate support is provided.
• Must have full range of motion with arms to clean ceilings and walls.
• Ability to effectively communicate and work with others.
• Ability to follow instructions and schedules.
• Maintains general work areas clean and organized. Adheres to Good Manufacturing Practices (GMPs) while using proper gowning procedures.
• Ability to produce legible handwriting on documents while following Good Documentation Practices (GDPs).
• Maintain a safe work environment and follow safety policies/best practices.
• Ability to adhere to attendance and timekeeping policies.
• Ability to read and perform basic math calculations. Working knowledge of metric system, scale procedures and liquid measure procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, employee is constantly required to move and access production equipment and other office machinery. Employee is constantly required to communicate information and ideas so that others will understand. While communicating, employee is required to be attentive and be able to react quickly to sounds. While performing the duties of this Job, the employee is regularly required to observe details at close range (within a foot of the observer). Constantly operates, uses, prepares, inspects, places, detects and positions production equipment and other office machinery. Employee is consistently required to remain in a stationary position for up to 75% of the time. Employee will need to constantly position self to operate production equipment and other office machinery. Regularly transports and positions items up to 55 lbs. (25 kg) and occasionally transports and positions items up to 200 lbs. (91 kg) assisted by ancillary equipment. Must be able to work in both cold and hot environments and on concrete floors.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is intermittently exposed to fumes or airborne particles. The employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually loud.

This job description is subject to change at any time.