Engineer – Validation (2 Years Contract)

B Braun; Bayan Lepas; On-site; MYR 150,000 - 200,000; Full time

Job summary

B Braun is seeking a Validation Engineer to join their team in Bayan Lepas. The role involves coordinating compliance and validation activities, leading training for validation procedures, and supporting production during trial runs. Candidates should possess a degree in Science or Engineering and have validation experience, ideally in a sterile manufacturing or pharmaceutical environment.

Qualifications

• 1-3 years validation experience required.
• Experience in medical or pharmaceutical industries is an advantage.

Responsibilities

• Coordinate validation execution and maintain Master Validation Plan.
• Serve as Coordinator/Trainer for validation training needs.
• Assist in qualification and validation activities for various projects.

Skills

Knowledge of regulatory requirements under PICs and EUGMP

Sterile manufacturing background

Education

Degree in Science or Engineering (Biotech, Microbiology, Mechanical)

Job description

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Coordinate/support the Head of Validation Team in executing Qualification and Validation in compliance with regulatory requirements by maintaining the Master Validation Plan, updating Validation Programs, and preparing validation procedures and documents.

Act as a key member in the Pharma Process Risk Analysis Team to ensure compliance for measuring devices used in validation, including handling, maintenance, and calibration. Follow up on corrective and preventive actions related to validation and compliance issues.

Additionally, serve as the Coordinator/Trainer for Pharma validation/qualification training needs, support production during trial/test runs to establish process parameters, support production projects as a key project team member, and perform internal quality inspections.

The incumbent is also responsible as Change Control Coordinator, assisting in qualification and validation activities for projects across the Asia Pacific region through resource planning and management.

For senior positions, responsibilities include heading the Validation Team, ensuring compliance in Pharma Plant qualification and validation, acting as Project Manager for Pharma Projects, and conducting supplier qualification and internal audits.

Requirements:

• Degree in Science or Engineering (e.g., Biotech, Microbiology, Mechanical)
• 1-3 years validation experience
• Knowledge of regulatory requirements under PICs and EUGMP
• Sterile manufacturing background and experience in medical or pharmaceutical industries are advantages

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Your application will include the following questions:

• Expected monthly basic salary
• Years of experience as a Validation Engineer