Fill Technician

ROLE SUMMARY

An Inhalation (IDD) Filling Technician is to manufacture the filled aerosol vials according to the requirements of the product, which are documented in batch record documentation and SOPs. Collects quality samples as required by the batch documentation. Assures that equipment is properly & correctly cleaned, the correct components are used per the batch record, and that all filling processes are compliant with the established methods and procedures. Ensures that all filling lots are completed to meet production timelines and goals.

ROLE RESPONSIBILITIES

• Performs cleaning and clean check procedures of the filling lines
• Operates filling equipment and assures that process parameters are monitored and within range for the product being manufactured, documented in the batch record.
• Performs filling equipment change-over and set-up operations in a timely and efficient manner
• Operates filling equipment per established operating, quality, and safety practices and procedures
• Utilizes the correct cleaning procedures
• Ensures the HMI interface has the correct program selection
• Able to troubleshoot routine equipment problems and recognizes when supervision and maintenance should be notified; sets goal to minimize equipment down time per established targets
• Keeps filling equipment running efficiently and per the production plan; immediately communicates with FOT management any issues that prevent equipment from running as scheduled
• Stages and maintains supply of raw materials for an efficient and organized filling operation
• Maintains a clean and orderly work area
• Knows and uses good safety practices, takes ownership for running a safe operation, promptly communicates unsafe situations, identifies opportunities for improving safety and actively participates in safety programs
• Anticipates and plans for lot kitting, staging and filling operations for the efficient transition to the next lot
• Assures that the status of current and upcoming filling processes are communicated to the next shift’s technician
• Solid understanding and knowledge of in-process and finished product quality requirements
• Accurately records filling lot information on documents, in M.O.s, log books, labels, etc, in accordance with SOP, M.O. and cGMP requirements in pharmaceutical environment
• Sets error-free goals for their work as well as for the entire filling team; works to the successful completion of those goals
• Recognizes & communicates quality improvement opportunities that apply to the filling process
• Gives and accepts constructive feedback; provides input on the performance of operators and agency workers
• Always wears appropriate personal protective equipment (PPE) per EHS requirements when working on department processes; assures that co-workers also follow PPE requirements

Secondary Job Responsibilities:

• Performs material handling operations as required
• Operates manual & powered pallet jacks and drum handlers; is required to operate a fork lift
• Functions as the SME filling technician for training purposes for all of the required filling equipment and processes
• As required, participates in engineering equipment and process improvement projects
• May be required to temporarily change shifts, work mandatory overtime or to help in other sections/departments in IDD and to attend overtime meetings
• May be required to perform cleaning of fill table parts
• Takes the initiative to help when required or needed within the total production operation
• Hazardous Waste Duties including handling or generating hazardous waste.
• Hazardous Waste Duties including preparing hazardous waste for shipment and/or loading hazardous waste onto transport units
• Follows procedures for Vorne usage on the lines.
• When required, may be asked to cover for and/or relieve packaging lines, after being trained in the area
• Performs other duties as requested

BASIC QUALIFICATIONS

• Excellent attention to details is essential
• Must become certified in job performance within the specified amount of time allowed
• Uses a calculator and has good basic math skills including metric conversions and percentages
• Excellent team work & interpersonal skills, able to effectively communicate process and equipment information to co-workers and FOT management
• Physical effort involves lifting 25-65 lbs (latter on occasion); push/pull weight of approximately 310-360 lbs utilizing a dolly, when handling drums of ethanol for formulating and/or tank cleaning
• Good mechanical skills; ensures that filling equipment is correctly assembled and operating per established standards and procedures
• Uses good time management; plans daily tasks for an efficient operation and the effective use of resources
• Must be able to follow written and verbal instructions; able to read, write legibly, understand and communicate in English

Must be able to perform the essential functions of the position with or without a reasonable accommodation.

• Attend and participate in the Tier 1 Process.
• Proficient for basic use of D365 system to support production needs