Filling Technician

Kindeva Drug Delivery•Los Angeles, CA

1d•Onsite

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make 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.

Requirements

Excellent attention to details is essential
Must be able to follow written and verbal instructions; able to read, write legibly, understand and communicate in English
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 teamwork & 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 perform the essential functions of the position with or without a reasonable accommodation.

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