As a Senior Validation Engineer II supporting the Manufacturing Team, you will be trusted to work at the Batam Plant. The candidate will be will be leading a team of Validation Engineers for the Tech Transfer project in the validation/ qualification activities for Processes, Equipment, Computerized Systems, Utilities, Facilities and Cleaning Procedures. In this role, a typical day will include: Write the validation plan including complex process validations Review validation/qualification written by the Validation Engineers Preparation, review and remediation of validation protocols Takes a leadership role in the project team and project management Communicates with the project team, site management and global project stakeholders Will visit the transferring site to learn the process and become receiving site expert Expected to have an expert level of understanding of validation and strong project management skills WHAT YOU’LL BRING TO ALCON: Bachelor Degree in Science or Engineering With a minimum of 7 years experience in manufacturing/ manufacturing science & technology/quality / technical development in medical device or pharmaceutical manufacturing Experience in complex projects Experience leading a team of Validation Engineers Deep understanding of Process Validations and Validation types Strong understanding of requirements and regulations of FDA, ISO, etc Fluent in English and local language Strong ability in reviewing and writing technical reports This role will be required to travel
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