12 Jul
Manufacturing Automation Engineer
California, Carpinteria , 93013 Carpinteria USA

Vacancy expired!

Hands On Manufacturing/Automation Engineer-Carpinteria, CAIn this highly visible and diverse role, you will provide hands-on production equipment support, troubleshooting, repairing and maintaining essential robotics and automation machinery. You will manage capital equipment and improvement projects, as well as work closely with vendors and contractors. You will also partner with QA on preparing and approving validation and other technical documents and procedures essential for regulatory compliance.Responsibilities

  • Provide hands-on engineering support, troubleshooting and maintenance of robotic and automated HMLV production floor equipment in a 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 a focus on root cause(s). Lead and assist with defining and implementing corrective and preventive actions (CAPA), and resolution to audit findings (NCR, SCAR, etc.).
  • Prepare, complete and support validations (IQ/OQ/PQ/SQ) to meet applicable FDA and regulatory requirements.
Required Knowledge, Skills & Abilities
  • Bachelor's 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, SQ (Part 11)
  • 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, Siemens NX experience
  • Experience with SAP, Agile, Electronic Batch Records (EBR) or Manufacturing Execution Systems (MES), and SCADA
  • Prior hands-on experience with programming Fanuc and Denso robots, Omron and Allen Bradly PLC, HMIs, Cognex Vision Systems, Zebra, and Sato Labelers
  • Knowledge of Industry 4.0, AI, predictive analytics, Machine Learning , Data Science, and touchless transactions.
Volt is an Equal Opportunity

Vacancy expired!


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