ROLE SUMMARYAn 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 RESPONSIBILITIESPerforms cleaning and clean check procedures of the filling linesOperates 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 mannerOperates filling equipment per established operating, quality, and safety practices and proceduresUtilizes the correct cleaning proceduresEnsures the HMI interface has the correct program selectionAble to troubleshoot routine equipment problems and recognizes when supervision and maintenance should be notified; sets goal to minimize equipment down time per established targetsKeeps filling equipment running efficiently and per the production plan; immediately communicates with FOT management any issues that prevent equipment from running as scheduledStages and maintains supply of raw materials for an efficient and organized filling operationMaintains a clean and orderly work areaKnows 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 programsAnticipates and plans for lot kitting, staging and filling operations for the efficient transition to the next lotAssures that the status of current and upcoming filling processes are communicated to the next shift’s technicianSolid understanding and knowledge of in-process and finished product quality requirementsAccurately 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 environmentSets error-free goals for their work as well as for the entire filling team; works to the successful completion of those goalsRecognizes & communicates quality improvement opportunities that apply to the filling processGives and accepts constructive feedback; provides input on the performance of operators and agency workersAlways wears appropriate personal protective equipment (PPE) per EHS requirements when working on department processes; assures that co-workers also follow PPE requirementsSecondary Job Responsibilities:Performs material handling operations as requiredOperates manual & powered pallet jacks and drum handlers; is required to operate a fork liftFunctions as the SME filling technician for training purposes for all of the required filling equipment and processesAs required, participates in engineering equipment and process improvement projectsMay be required to temporarily change shifts, work mandatory overtime or to help in other sections/departments in IDD and to attend overtime meetingsMay be required to perform cleaning of fill table partsTakes the initiative to help when required or needed within the total production operationHazardous Waste Duties including handling or generating hazardous waste.Hazardous Waste Duties including preparing hazardous waste for shipment and/or loading hazardous waste onto transport unitsFollows 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 areaPerforms other duties as requestedBASIC QUALIFICATIONSExcellent attention to details is essentialMust become certified in job performance within the specified amount of time allowedUses a calculator and has good basic math skills including metric conversions and percentagesExcellent team work & interpersonal skills, able to effectively communicate process and equipment information to co-workers and FOT managementPhysical 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 cleaningGood mechanical skills; ensures that filling equipment is correctly assembled and operating per established standards and proceduresUses good time management; plans daily tasks for an efficient operation and the effective use of resourcesMust be able to follow written and verbal instructions; able to read, write legibly, understand and communicate in EnglishMust 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