Provide guidance and ensure compliance with the Quality System Regulations including FDA, ISO 13485, and applicable international regulations. Develops and implements The Automated equipment technician position is responsible for operating, troubleshooting and maintaining automated production equipment in the “clean room” production area with focus on product quality, process efficiency, and good documentation practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Perform equipment setup and operation of automated production equipment in the “clean room” production area, to include the colimatic form, fill and seal machine as well as other production equipment.
- Ensures work area is properly staged and set up prior to beginning each job. Always performs and documents line clearance before and after each job.
- Maximize equipment uptime including regular cleaning, troubleshooting, equipment maintenance, and performing minor adjustments and repairs.
- Reviews work order, organizes materials and the work area to ensure efficient operations.
- Adheres to manufacturing schedule and completes tasks in a timely manner.
- Observes and accurately records key information as required by the manufacturing forms used in the process. Proofs work and ensures records (DHR) are accurate.
- Maintains a clean, orderly, and safe work area in accordance with GMP
- Adheres to equipment maintenance schedules. Works with internal and external maintenance technicians and engineering staff ensuring equipment is properly calibrated and maintained.
- Maintain production and quality metrics for the equipment
- Records and tracks maintenance and repairs through the QCBD equipment module as appropriate.
- Interface with quality, engineering, and manufacturing management to ensure downstream goals are being met with emphasis on continuous process improvement.
- Trains new employees and cross trains current employees as requested.
- Updates work instructions as needed.
- Perform other duties as assigned
LOCATION: CP Medical
REPORTS TO: Area Production Supervisor
SUPERVISES: No Direct Reports
- High School Diploma or Associate degree in an engineering technology or related field preferred.
- Education or equivalent experience in automation technology with working knowledge in electronics, mechanical and machine function preferred.
- Minimum of 2-4 years or more related experience and/or training
- Experience in medical device or food industry desired but not required.
- Leadership of a small teams or work groups.
- Proficiency in automated equipment and machinery operation, troubleshooting, and maintenance.
- Working knowledge of PLC, electronics, and mechanical systems.
- Ability to lead small production and process improvement teams with emphasis on continuous improvement.
- Ability to work overtime as workload dictates.
- The job is typically performed under comfortable working conditions in an office, warehouse or clean room environment where light manufacturing is performed; any disagreeable elements are generally absent during normal performance of job. Works with production equipment and machinery with moving parts.
- Ability to lift 501bs.
This position has access to or may be exposed to confidential and propriety Company information. Therefore, a high level of confidentially must be maintained at all times with any Company information.
LIMITATIONS AND DISCLAIMER
The above position description is meant to describe the general nature and level of work being performed; the position description is not a comprehensive or exhaustive list of all duties, responsibilities of skills required for the position. Management has the right to assign or reassign duties and responsibilities to or from this position at any time.
To perform this position successfully, the employee must be able to satisfactorily perform each essential position duty and responsibility. All position requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
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