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 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