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Validation Engineer (Process Validation) - 1815458

🌟 Join Our Team as a Validation Engineer – Process Development! 🌐

🛡️ Medical Device Industry 📈

Location: North Area, Puerto Rico (Onshore) - 100% Onsite Work 🏝️

Purpose Statement:

As a Validation Engineer in Process Development, you will play a crucial role in developing and reviewing documentation and procedures. Your expertise will be instrumental in providing automation systems testing and validation to support Process Development and/or Manufacturing Process Engineering. 🔍🚀

Key Responsibilities:

  • Support process and/or equipment validation activities (IQ, OQ, PQ) 🛠️
  • Conduct process performance qualification activities and develop Master Validation plans for new processes or products. 📈
  • Review and develop process validation protocols and reports; provide support during validation activities in collaboration with other functional areas. 📋
  • Collaborate with the Process Development team to efficiently qualify new processes; assist in statistical sampling plans and other development procedures. 🤝
  • Design and develop in-process and receiving quality systems for new processes and components. 🛡️
  • Generate equipment documentation, including entries, evaluations, PM, and calibration procedures. 📄
  • Define gauges, tools, and equipment for the developed test methods. 🔧
  • Generate manufacturing instructions for newly developed processes. 📦
  • Collaborate cross-functionally with other departments to accomplish Process Development tasks. 👥

Quality System Requirement:

In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. 🌐

  • Assure that appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the Quality Policy. 💼
  • Establish and promote a work environment that supports the Quality Policy and Quality System. 🌟

🌐 Discover a Rewarding Career - Apply Now! 🚀 #ValidationEngineer #ProcessDevelopment #QualityFirst 🌈💼

Thank you. We will be in contact soon.

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