Senior Validation Eng II

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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