Facility Engineer

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

• What Facility Engineer Jobs are in Jakarta

Showing 14 Facility Engineer jobs in Jakarta

Validation Engineer - Pharmaceutical Facilities

Our client is seeking an experienced Validation Engineer to join their critical engineering team in Balikpapan . This role is essential for ensuring that all pharmaceutical manufacturing equipment, facilities, and processes meet rigorous regulatory standards through comprehensive validation protocols. You will be responsible for developing, executing, and documenting validation activities to guarantee the reliability and compliance of our manufacturing operations. The ideal candidate will have a strong technical background and a deep understanding of validation principles within the pharmaceutical industry, contributing to the consistent delivery of high-quality medicines.

Our client is seeking an experienced Validation Engineer to join their critical engineering team in Balikpapan . This role is essential for ensuring that all pharmaceutical manufacturing equipment, facilities, and processes meet rigorous regulatory standards through comprehensive validation protocols. You will be responsible for developing, executing, and documenting validation activities to guarantee the reliability and compliance of our manufacturing operations. The ideal candidate will have a strong technical background and a deep understanding of validation principles within the pharmaceutical industry, contributing to the consistent delivery of high-quality medicines.

About the Role

Our client is seeking an experienced Validation Engineer to join their critical engineering team in Balikpapan . This role is essential for ensuring that all pharmaceutical manufacturing equipment, facilities, and processes meet rigorous regulatory standards through comprehensive validation protocols. You will be responsible for developing, executing, and documenting validation activities to guarantee the reliability and compliance of our manufacturing operations. The ideal candidate will have a strong technical background and a deep understanding of validation principles within the pharmaceutical industry, contributing to the consistent delivery of high-quality medicines.

Key Responsibilities

• Develop and execute validation master plans (VMPs) and individual validation protocols (IQ, OQ, PQ) for equipment, utilities, and processes.
• Ensure all validation activities are conducted in compliance with FDA regulations , cGMP , and other relevant 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.

Requirements

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical) or a related scientific discipline.
• Minimum of 3 years of experience in validation engineering within the pharmaceutical or biotech industry.
• Thorough understanding of cGMP , FDA guidelines, and validation principles (IQ/OQ/PQ).
• Experience with validation of pharmaceutical manufacturing equipment and utilities.