Senior Quality Engineer

3 weeks ago

Hillsboro OR, United States Motion Recruitment Full time

🚀 Now Hiring: Quality Validation Specialist / Engineer 🏭 About the Role We are seeking an experienced Quality Validation Specialist / Engineer to support a drug product and finished goods manufacturing organization responsible for delivering commercial and pipeline products. This role provides critical quality oversight to ensure manufacturing systems and processes remain compliant, validated, and inspection-ready. 🔍 What You’ll Do ✅ Provide quality oversight for site qualification and validation programs ⚙️ Support qualification and validation of equipment, facilities, and utility systems 💻 Oversee validation of GMP computerized systems 🧪 Provide quality oversight for drug product manufacturing, cleaning, sterilization, and analytical methods 📋 Guide internal teams on best practices for compliant and reproducible validation execution 🔄 Review and approve changes impacting the validated state and/or requiring qualification or validation 📝 Review and approve validation documentation in alignment with quality system requirements ⚠️ Provide oversight and input on qualification/validation deviations and exceptions 📊 Analyze complex issues requiring evaluation of multiple variables and cross-functional impact 🤝 Collaborate with cross-functional teams and exercise sound technical and quality judgment 👩 🔬 Who You Are 🎓 Bachelor’s degree with 5–10 years of relevant industry experience , or equivalent qualifications 🏥 Experience in the biopharmaceutical or pharmaceutical industry in technical or quality validation 📘 Strong knowledge of qualification and validation principles 📏 Ability to interpret and apply quality standards and regulatory requirements 🧠 Strong decision-making skills related to quality and technical topics 📜 Solid understanding of cGMP or equivalent regulations ⏰ Flexible in problem-solving approach and work hours to meet business objectives 🤝 Strong collaboration skills with the ability to quickly build rapport with team members

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