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 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 Lead and/or execute commissioning activities including FAT, SAT, and field commissioning. Ensure systems are installed and operating according to design specifications. Coordinate startup activities with vendors and contractors. Review and approve commissioning documentation and test results. 3. Qualification Execution (IQ/OQ/PQ) Author, review, ...