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

• Develop and implement overall C&Q strategies aligned with project objectives and regulatory requirements.
  
• Define system boundaries and identify direct and indirect impact systems.
  
• Lead risk assessments using methodologies such as ISPE Baseline and ASTM E2500.
  
• Develop C&Q plans, schedules, and resource forecasts.
  

2. Commissioning Activities

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