- This position must adhere to all SOPs, cGXPs, and plant quality, safety, and documentation systems requirements.
- Other related duties essential to these operations or special assignments as required.
- Knowledge of HMI operations.
- Operates in Grade C, D environments and has knowledge of cleanroom technique and processes (aseptic).
- Filling Technician I reports to Operations. This incumbent performs as a technical resource for other operations colleagues in their assigned area.
What You Will Achieve
- Read and interpret detailed blueprints and schematics
- Operate small hand and power tools in a safe manner
- Follow oral and written instructions
- Work effectively with various levels of employees
- Learn department and company policies and procedures
- Work independently with minimal supervision as required
- Ability to understand changeovers, adjust, PM and repair manufacturing equipment
- A working knowledge of basic mechanics, drive systems and lubrication principles
- Ability to work safely with electrical and electronic principles
- The ability to use voltmeter to test for power presence
- Communicates openly and clearly with line personnel and supervision to accomplish manufacturing goals.
- Follow SOPs, cGMPs, batch records, BOMs.
- Notify Group Leader/Supervisor of all safety and quality issues.
- Documents all maintenance performed through the use of the work order system and maintenance log books.
- Keeps accurate records as needed for filling manufacturing and prepares the process steps and parameters with the utmost attention to detail as specified in the batch record
- Manage line efficiencies and make suggestions for improvements
- Provides recommendation and plan of action to the supervisor on the needed repair of the equipment.
Qualifications
- HS diploma with 2-4 years of GMP manufacturing exp
- Or Associates Degree in Science or Technology and 0-2 years GMP manufacturing exp
- Fundamental knowledge of cleanroom technique (Aseptic)
- Knowledge of the general trades: i.e., construction, electrical, machine shop. Knowledge of basic mathematics.
- Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices.
- Must know general shop safety practices including handling and storage of potentially dangerous equipment.
- Ensuring adherence to all plant safety rules in area of responsibility
- Must be self-motivated, able to work independently and have a problem solving mindset.
- Must be able to read, interpret, and perform job duties as prescribed in the operating procedure.
- Must demonstrate experience and competence in following detailed instructions.
- Must be able to read and interpret equipment data and demonstrate ability to communicate work requirement and problems in a concise and accurate manner.
- Must be able to confirm cleaned equipment meets the requirements of “visually clean” and passing all critical process parameters.
- Must be able to work in a controlled temperature environment wearing clean room attire. On occasion, steam, noise, chemical odors, and fumes may be present.
- Required to wear personnel protective equipment as indicated by area standard operating procedures.
- Must have the ability to recognize when processes, procedures, equipment, product, commodities, etc are out of specifications.
- Stand up to 8-12 hours per shift, sit for up to 2-4 hours per shift, twist at waist 10 times per hour, regularly lift up to 20 pounds per activity 5 times per shift, occasionally lift a maximum of 50 pounds per activity 1 time per shift, walk, climb stairs, climb ladders/walk on catwalks
- Use computer terminal 1 hour per shift, respond to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, work around moving equipment, work with chemicals, work in hearing conservation area, work on knees occasionally