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:
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Write the validation plan including complex process validations
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Review validation/qualification written by the Validation Engineers
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Preparation, review and remediation of validation protocols
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Takes a leadership role in the project team and project management
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Communicates with the project team, site management and global project stakeholders
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Will visit the transferring site to learn the process and become receiving site expert
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Expected to have an expert level of understanding of validation and strong project management skills
WHAT YOU’LL BRING TO ALCON:
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Bachelor Degree in Science or Engineering
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With a minimum of 7 years experience in manufacturing/ manufacturing science & technology/quality / technical development in medical device or pharmaceutical manufacturing
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Experience in complex projects
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Experience leading a team of Validation Engineers
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Deep understanding of Process Validations and Validation types
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Strong understanding of requirements and regulations of FDA, ISO, etc
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Fluent in English and local language
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Strong ability in reviewing and writing technical reports
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This role will be required to travel
ATTENTION: Current Alcon Employee/Contingent Worker
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