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EQVAL

Validation Engineer

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeDorado, Puerto RicoIn-person

About the Job

Requirements

  • A bachelor's degree in Engineering is required; Electrical and Mechanical backgrounds are preferred.
  • Previous experience in a regulated industry such as Pharma, Biotech, or Medical Devices is required.
  • Experience with automated manufacturing systems and equipment, including laser welding, heat bonding, injection molding, and vision systems, is required.
  • Experience with automation and controls, tooling, fixtures, and test method development is required.
  • Proficiency in DOE, FMEA, CAPA, and root-cause investigation is required.
  • Good technical writing skills are required.
  • Fluency in English and Spanish is required.

Responsibilities

  • Perform process validation and equipment qualification activities and prepare related reports, including IQ, OQ, and PQ.
  • Develop Master Validation Plans.
  • Generate equipment documentation, including evaluations and preventive maintenance/calibration procedures, and prepare manufacturing instructions.
  • Design and develop in-process and receiving inspection systems for new components and processes.
  • Characterize, optimize, and improve manufacturing processes through DOE, PFMEA, and risk analysis.
  • Work with laser welding, heat bonding, injection molding, vision systems, and automation technologies, including PLCs, servos, pneumatics, and sensors.

Desired Qualifications

  • Electrical or Mechanical engineering background.

About the Company

Company size
Not listed
Company stage
Not listed
Total funding
Not listed
Headquarters
Lausanne, Switzerland
Founded
2012

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