**Process Technician -BFS -Extrusion**
**Mandatory: Experience with Plastic Inject Molding. Pharma or Medical Devices Industry.**
Manufacturing Company located in Kansas is searching for a **Process Technician -BFS. **The incumbent is responsible to support primary manufacturing operation on the Blow Fill Seal (BFS) line by operating processes, machinery, and packaging equipment, assure compliant to the cGMP's, monitoring and perform activities to keep the process/machinery and equipment up and running, meeting the process and maintenance requirement, Follows the designated procedures and policies applied by the Company.
The process technician level II is capable to run as per process machine specification/requirements in at least 11 (from 1 p to 11) critical systems for BFS process:
**1. **CIP + water generation system, able to perform valves opening as required.
**2. **Steam generator system for setam in place activities.
**3. **SIP execution and trouble shooting.
**4. **Pall "Flowstar" or similar equipment for filters integrity test.
**5. **Filter integrity test.
**6. **Sterile Air System.
**7. **The vacuum resin system and compressed air.
**8. **Regrinder and vacuum system.
**9. **Blow, fill and seal machine, process, maintenance and operation.
**10. **Bottle pack "Rommelag" Machine process, maintenance, and operation.
**11. **Singulation process and machinery process, maintenance, and operation.
Essential Functions:
- Able to operate at least three critical processes/systems or equipment at BFS area from system number 1 up to 11 to ensure efficient operations and high-quality product.
- Perform machine process turn around; CIP, SIP, cleaning and sanitization, filter integrity test and line start up.
- Able to identify all risk and safety conditions that can compromise the operator's wellbeing and process/machinery equipment.
- Perform tools/mold and process change over, line/machine set-up, line clearance, MPR/MBR, and operate production equipment in accordance with current manufacturing practices and safety standard operating procedures.
- Follow-up and execution of the production schedule.
- Provides oversight to production staff on the assigned line and assumes accountability for the work performed.
- Actively completes batch record paperwork and documents for compliance to requirements.
- Collaborates with operational personnel (line leader, supervisor, engineering, leader, and maintenance technicians, etc.), in monitoring and supporting the production plan.
- Conduct process control and adjust, if necessary, based on the operations SOP, taking into consideration the performance and scrap of the process.
- Monitor the process and operating systems. Able to elaborate production daily reports and capture production number into the ERP system IQMS.
- Adjust and trouble shoot the process/lines/equipment for smooth operation.
- Monitor and adjust production processes to improve efficiency or equipment for quality and productivity.
- Detect and repairs process anomalies in the equipment and requests support from the team and communicate with the production supervisor.
- Consult the technical manual to troubleshoot problems with BFS equipment, process, machinery making improvements.
- Execute preventive maintenance in accordance with the schedule and requirements.
- Conduct total predictive maintenance in accordance with process and machinery requirements.
- Plan and lay out work to meet production and schedule requirements.
- Provide and support training to other technicians, create training material.
- Create records and support the machinery availability to maintain positives trends on all operations KPI's.
- Perform 5's in accordance with the best manufacturing practices.
- Assure the quality of the product by following the cGMP and the company's Policies.
- Trained/certified on fork truck operation to move finish goods from production to warehouse and to restock components to the production floor.
- Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities.
- Follow the escalation path and communication process to solve process and machinery issues.
- Create daily productivity reports, downtime and any other related KPI from assigned areas as part of standard job.
- Support the continuous improvement.
**EDUCATION / EXPERIENCE REQUIREMENTS**:
- Industrial, Mechanical or Electromechanical Engineering Degree or related bachelor.
- Bilingual: English - Spanish
- 4 Years minimum experience in Plastic Injection Molding machines.
- Drawings Reading, GD&T Training or Certification
- Measuring Instruments (multimeter, Vernier, Micrometer, Manometers, etc.)
- Pneumatic, Electrical Wiring, Control and Industrial Mechanics
- Basic Knowledge on PLC
- Time availability to shift rotation
- 5's applied to daily basis job
- Changer Overs (SMED)
- Basic Knowledge on Hydraulics
- Preventive Maintenance
- Total Predicti