Opportunity Description
Job Description
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.
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