Setter (APU 1-D)
PharmaQuality Assurancegmpinform
Job description
With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing. Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon). We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities. Position Purpose : The APU Setter is responsible for the startup, operation and TPM maintenance of molding and assembly equipment and the packaging of packaging of molded and/or assembled components per company and customer specifications.  KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:    Supports and has knowledge of responsibilities of operator level 1 and 2  Complete visual inspection of product per production specification for defects   Maintain clean workspace and 55 Standards in work area daily/weekly/monthly  Load the validated master cycle parameters into the Injection Molding machine at each startup.   Load programs into and align automated and robotic systems.   Ensure Injection Molding machines are running to standard and ensuring product quality meets specification at each startup.   Troubleshoot small and mid-size problems in processes, escalate to Setter Level 2 or Maintenance as needed  Answer alarms as needed, start and stop machines after initial start-up  Retrieve required documentation out of TMS to assist with quality related decisions.   Perform line clearances as required.   Clean injection molds as required per work instructions  Pull and set mold  Perform color changes and material lots as required, and complete traceability documentation  Perform assembly start up batches/shots for product change/new version (same reference)  Complete Assembly, Injection Molding and auxiliary equipment (TPM) Total Productive Maintenance -Level 1.   Complete cycle checklist  Perform LOTO (lock out/tag out) of any unsafe equipment  Maintain Lean initiatives and participate in lean projects   Provide suggestions and take active role in Process Improvements to eliminate non-value-added activity   Support and maintain all policies of the company including but not limited to ISO Standards, Health and Safety   Requirements, Continuous Improvement, GMP and standard work procedures   Other duties as assigned   POSITION REQUIREMENTS:   High School Diploma, GED or equivalent work experience (required)  Able to frequently lift up to 50lbs.  Stand and walk 90% of shift   Ability to bend, stoop, reach, push, pull, grab and climb  Satisfy vision testing requirements of the job  PREFERRED KNOWLEDGE/SKILLS:  Basic math skills  PC skills  Basic mechanical skills  Injection Molding and/or robotic knowledge    WORK ENVIRONMENT:   Works in a clean manufacturing and warehouse environment that may include moderate noise levels  POSITION REQUIREMENTS:   High School Diploma, GED or equivalent work experience (required)  Able to frequently lift up to 50lbs.  Stand and walk 90% of shift   Ability to bend, stoop, reach, push, pull, grab and climb  Satisfy vision testing requirements of the job  PAY RANGE:  $25.00 USD - $40.00 USD Hourly, 10% nights shift differential  (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.) SHIFT SCHEDULE:  This is a 223 Days 12 hours position, 6:00 PM - 6:00 AM. All your information will be kept confidential according to EEO guidelines. For US Benefits, CLICK HERE . Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.
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