Sr. Validation Engineer

Alcon; Batam; On-site; IDR 320,000,000 - 520,000,000; Full time

Job summary

Alcon in Batam, Indonesia, is seeking a Senior Validation Engineer to support the Manufacturing Team. You will implement and execute validation/qualification activities for processes, equipment, computerized systems, and facilities.

The role requires 5–10 years in manufacturing or quality disciplines in medical devices or pharma, a Bachelor's in Science or Engineering, fluent English and local language, and strong skills in writing technical reports and reviewing documentation.

Qualifications

• Bachelor’s Degree in Science or Engineering.
• 5–10 years experience in manufacturing/ manufacturing science & technology/quality / technical development in medical device, pharmaceutical manufacturing or food & beverage manufacturing.
• At least 5 years of experience in executing validation activities in complex projects.
• Good understanding of requirements and validation lifecycle.
• Fluent in English and local language.
• Strong ability in reviewing and writing technical reports.

Responsibilities

• Execute and support site validation/qualification activities
• Support Validation Efforts for Tech Transfer projects
• Preparation, review and remediation of validation protocols
• Training of validation protocols, site validation SOPs
• Support validation activities for large capital procurement projects
• Ensure compliance and provide technical support to the validation team

Skills

Validation lifecycle

Technical report writing

Quality systems

English proficiency

Local language proficiency

Education

Bachelor's Degree in Science or Engineering

Job description

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As a Senior Validation Engineer supporting the Manufacturing Team, you will be trusted to work at the Batam Plant. The candidate will be supporting and executing the validation/ qualification activities for Processes, Equipment, Computerized Systems, Utilities, Facilities and Cleaning Procedures.

In this role, a typical day will include:

Execute and support site validation/qualification activities

Support Validation Efforts for Tech Transfer projects

Preparation, review and remediation of validation protocols

Training of validation protocols, site validation SOPs

Support validation activities for large capital procurement projects

Ensure compliance and provide technical support to the validation team

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree in Science or Engineering
• 5 - 10 years experience in manufacturing/ manufacturing science & technology/quality / technical development in medical device, pharmaceutical manufacturing or food & beverage manufacturing
• At least 5 years of experience in executing validation activities in complex projects
• Good understanding of requirements and validation lifecycle
• Fluent in English and local language
• Strong ability in reviewing and writing technical reports