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Senior Validation Eng II

Alcon Indonesia

Batam

On-site

IDR 100.000.000 - 200.000.000

Full time

Today
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Job summary

A medical device company in Batam is seeking a Senior Validation Engineer II to lead validation activities for the Tech Transfer project. The ideal candidate will have a Bachelor's degree in Science or Engineering and at least 7 years of experience in manufacturing. Responsibilities include writing validation plans, managing projects, and collaborating with global stakeholders. Strong leadership and project management skills are essential, along with fluency in English.

Qualifications

  • Minimum 7 years of experience in manufacturing science & technology.
  • Experience in complex projects and in leading a team of Validation Engineers.
  • Deep understanding of Process Validations and regulatory requirements.

Responsibilities

  • Write the validation plan including complex process validations.
  • Review validation documents prepared by Validation Engineers.
  • Prepare and review validation protocols.
  • Lead the project team and manage projects.
  • Communicate with project management and stakeholders.
  • Visit transferring sites to become the expert.

Skills

Leadership in project management
Expert-level understanding of validation
Strong project management skills
Fluent in English
Strong ability in reviewing and writing technical reports

Education

Bachelor Degree in Science or Engineering
Job description
Overview

Senior Validation Engineer II supporting the Manufacturing Team at the Batam Plant. The candidate will lead a team of Validation Engineers for the Tech Transfer project in validation/qualification activities for Processes, Equipment, Computerized Systems, Utilities, Facilities and Cleaning Procedures. This role requires leadership in project management and direct collaboration with site management and global project stakeholders. The position may require travel to transferring sites to learn processes and become the receiving site expert.

Responsibilities
  • Write the validation plan including complex process validations.
  • Review validation/qualification documents prepared by Validation Engineers.
  • Prepare, review and remediate validation protocols.
  • Take a leadership role in the project team and project management.
  • Communicate with the project team, site management and global project stakeholders.
  • Visit transferring sites to learn the process and become the receiving site expert.
  • Demonstrate expert-level understanding of validation and strong project management skills.
Qualifications
  • Bachelor Degree in Science or Engineering.
  • Minimum 7 years of 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.
  • Travel availability as required for the role.

Note: This description reflects the responsibilities and qualifications for the role and does not include unrelated company boilerplate.

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