Pharma Validation Engineer for Facilities

Star Energy Geothermal; Jakarta Pusat; On-site; IDR 200,880,000 - 357,120,000; Full time

Job summary

Our client in Balikpapan seeks an experienced Validation Engineer to lead validation activities for pharmaceutical manufacturing equipment, facilities, and processes, ensuring regulatory compliance and reliability of operations.

The role requires a strong technical background in validation principles, cross-functional collaboration, and the ability to develop, execute, and document validation protocols to deliver high-quality medicines.

Qualifications

• Bachelor's degree in Engineering (Chemical/Mechanical/Electrical).
• At least 3 years of validation engineering experience in pharma/biotech.
• Strong understanding of cGMP, FDA guidelines, and IQ/OQ/PQ.

Responsibilities

• Develop and execute validation master plans (VMPs) and individual validation protocols (IQ, OQ, PQ) for equipment, utilities, and processes.
• Ensure all validation activities comply with FDA regulations, cGMP, and other industry standards.
• Write comprehensive validation reports, summarize results, and provide recommendations.
• Troubleshoot validation deviations and discrepancies, and implement corrective actions.
• Collaborate with engineering, manufacturing, and quality assurance teams to support validation efforts.

Skills

Validation concepts

IQ/OQ/PQ

Regulatory compliance

Education

Bachelor's degree in Engineering (Chemical/Mechanical/Electrical)

Tools

IQ

OQ

PQ

Job description

Our client in Balikpapan seeks an experienced Validation Engineer to lead validation activities for pharmaceutical manufacturing equipment, facilities, and processes, ensuring regulatory compliance and reliability of operations.

The role requires a strong technical background in validation principles, cross-functional collaboration, and the ability to develop, execute, and document validation protocols to deliver high-quality medicines.