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