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Validation Engineer (Medical Device Environment) - 2331891

Title: Process Validation Engineer (Medical Device Environment) 🌟

📍 Location: Dorado, PR

🤝 100% on-site opportunity 📝

Purpose Statement: Develops and reviews documentation and procedures and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.

Key Responsibilities:

Educational Requirement:

🎓 At least a Bachelor's degree in Engineering or related fields is required.

Process Validation 🔧

  • Support process and/or equipment validation activities (IQ, OQ, PQ) 📋, process performance qualification activities, and develop Master validation plans for new processes or products.
  • Review and develop process validation protocols and reports 📝. Support other functional areas during the validation activities.
  • Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans 📊 and other development procedures.
  • Design and develop in-process and receiving quality systems for new processes and components 🔍.
  • Generate equipment documentation, such as equipment entries, evaluations, PM, and calibration procedures, as required 🛠️.
  • Define gages, tools, and equipment for the test methods developed 🔧.
  • Generate manufacturing instructions for new processes being developed 🏭.
  • Work cross-functionally with other departments to accomplish Process Development tasks 🤝.

Quality System Requirement:

  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures 🛡️.
  • Ensures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the client's Quality Policy ⚙️.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System 🌟.

If you're ready to make a significant impact in the medical device industry, we invite you to apply for this exciting opportunity! 🚀 Send your updated resume to with "Process Validation Engineer" in the subject line. We look forward to welcoming you to our team! 🌟

Thank you. We will be in contact soon.

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