Position Summary:
This position is a Manufacturing Technician that operates and make adjustments and / or repairs machine as necessary to achieve optimum performance and productivity.
Responsibilities: Essential Duties
Operate all assigned equipment, stop and / or start the machine whenever necessary, meaning cleaning, starting the machine after any electrical failure and other situations
Perform and oversee the standard work according to department SOP’s.
Work with the Mfg Lead and management to establish, implement, maintain, and enhance the standard work in the area
Conduct training for operators on standard work and trouble-shooting techniques, and evaluate the effectiveness of training.
Consult and actively participate together with the Automation, Process Engineering (Process and Products) and / or Quality Department personnel in the analysis of the manufacturing process to identify areas of opportunity for improvement. Recommend changes to operating procedures in order to improved quality and efficiency.
Follow and ensure adherence to cGMP's.
Contribute and participate in continuous improvement programs including LPMS, 5S, KATA, and Kaizen events.
Participate in the daily shift startup meeting.
Troubleshoot and resolve line stoppages, stop the machine if necessary to perform alignment of peripheral equipment or arrange assistance for its correction. Complete documentation required by procedures or specifications.
Perform preventive maintenance such as cleaning, greasing and lubricating the machinery.
During machine downtime, assist mechanic and/or engineers on maintenance activities.
Collect, pack and identify the production obtained. Perform visual and functional tests on the product.
Monitor production quality and take action according to the standard work / SOP.
Perform equipment setup and adjustment. Notify and keep the Automation, Manufacturing, Quality and Engineering personnel informed of any situation found in the machine that may affect its process and operation. (Eg. Processes, parts, guards, etc).
Perform line clearance per SOP
Complete appropriate documentation including batch records, log books, PM and DM as required, following good documentation practices. Prepare information board for the shift codes of your responsibility machines.
Perform cleaning, sanitizing and disinfecting of designated areas.
Maintain work area to the 5S standard. Maintain written information or production graphs, "down time", "setup time" or any other indicator that is established by the machine, in order to monitor its productivity or establish trends in it.
Adhere to all safety and good housekeeping regulations.
Expertise: Knowledge & Skills
Ability to read, write, understand, and effectively communicate job related information in English.
Basic computer skills including Microsoft Windows, Word, and Excel, and the ability to send/receive email.
Knowledge of company policies, procedures, cGMP's, and OSHA regulations.
Preferred Requirements
Experience in Radio Frequency (RF) Sealing with courses and demonstrated skills in technical areas (mechanics, electronics and electricity) Knowledge in measurement such as: Caliper, Micrometer, Optical Comparator. Read technical drawings. Knowledge of computer applications (Microsoft Office) PowerPoint).
Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc
Required:
AA degree or equivalent from a 2-year college or technical school or equivalent education/experience.
Minimum 2 years previous experience in the pharmaceutical/medical device industry or highly automated manufacturing plant.
Desired:
3 years prior experience in a manufacturing environment with automated production assembly.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 100 pounds.
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