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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