• Provide hands-on engineering support, trouble-shooting and maintenance of robotic and automated HMLV production floor equipment in regulated environment.


• Define, procure and support robotic and automated filling, labeling and packaging equipment (SOW, Functional Spec., FAT, SAT)


• Apply Project Management skills and tools to lead and support capital equipment and improvement projects.


• Resolve equipment failures with focus on root cause(s). Lead and assist with defining and implementing corrective and preventive actions, and resolution to audit findings.


• Prepare, complete and support validations (IQ/OQ/PQ) to meet applicable FDA and regulatory requirements.

Required Knowledge, Skills & Abilities

• Bachelor Degree in Mechanical, Electrical, Robotics, Automation, or other relevant Engineering & Technology disciplines with 5+ years of experience, or equivalent combination of education and experience.


• Prior hands-on working experience with Robotics & Automation, PLCs, HMIs, Vision Systems, Servos, and Labelers


• Prior experience maintaining robotic & automated equipment


• Prior experience with process/equipment validation: writing documentation and execution - IQ, OQ, PQ


• Strong technical, project management and documentation skills


• Self-starter, highly organized, complex problem solver with technical, detail-oriented mindset and strong analytical and communication skills


• Demonstrated ability to work in a regulated environment

Preferred Knowledge, Skills & Abilities

• Knowledge of FDA QSR requirements, ISO 13485, or other recognized international quality system standards


• Prior experience in working with and/or managing suppliers and/or subcontractors


• Experience with DI water systems, cold room management, central monitoring systems


• Experience with FMEA, DOE, SPC


• CAD, SolidWorks experience


• Experience with SAP, Agile, and Electronic Batch Records


• Prior hands-on experience with programming Fanuc and Denso robots, Omron and Allen Bradly PLC, HMIs, Cognex Vision Systems, Zebra, Sato and DataMax Labelers


• Knowledge of Industry 4.0, AI, predictive analytics and touchless transactions


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  ADDITIONAL INFO
  

  Robotics & Automation
  
  Project Management - Capital Equipment
  
  Validation/ISO Documentation
  
   

  
  
  

  1.       5+ years exp. with Robotics & Automation - Hands on experience working with automated manufacturing equipment

  
  
  

  2.       Project management experience (Capital Equipment) – replacing aging equipment

  
  
  

  3.       Validation experience – ISO Documentation experience (can train on this but must be willing to be trained on it)

  
  
  

  4.       Continuous improvement/Digitalization