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Sr. Engineer
We are seeking a highly motivated Senior Engineer with strong experience in Assembly and Packaging Processes to support commissioning, qualification, and characterization activities within a regulated manufacturing environment.
Key Responsibilities
1. Commissioning & Qualification (C&Q) Strategy and Planning
2. Commissioning Activities
3. Qualification Execution (IQ/OQ/PQ)
4. Documentation & Compliance.
5. Risk Management & Change Control.
6. Cross-Functional Collaboration
7. Process Characterization
Requisitos: Requirements: Requirements Doctorate degree, or Master’s degree with 2+ years of experience, or Bachelor’s degree in Engineering with 4+ years of experience. Experience in GMP-regulated manufacturing environments. Strong understanding of FDA, EMA, ISPE, and ASTM guidelines. Experience with validation lifecycle documentation and risk-based qualification approaches. Excellent technical writing, communication, and collaboration skills. Requiere Mucha Experiencia Requires Expert
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