GMP Validation Engineer — Automation & Computer Systems

Coalesce Management Consulting; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Coalesce Management Consulting is seeking an Automation & Computer System Validation Engineer for a leading healthcare and biopharma client in Singapore. You will support lifecycle management, commissioning, qualification and validation of automated equipment and computerised systems in a GMP manufacturing environment.

You will collaborate with Engineering, Quality Assurance, Manufacturing and vendors to ensure systems are specified, tested and maintained in a validated state across their

Qualifications

• Bachelor’s degree in automation, electrical, or related engineering field.
• At least 1 year in automation or computer system validation.
• Experience in GMP pharmaceutical manufacturing.
• Practical experience with Siemens or Rockwell PLC/HMI.
• Knowledge of validation lifecycle: URS, IQ, OQ, PQ, risk assessments.
• Familiarity with GMP, data integrity and change control.
• Strong written and verbal communication.

Responsibilities

• Support lifecycle of computerised and automated systems from design to retirement.
• Develop validation strategies and specifications.
• Prepare and execute commissioning and qualification docs.
• Perform IQ/OQ/PQ testing and create validation reports.
• Review system functionality, alarms, access, audit trails, data retention.
• Coordinate with project contractors and vendors.
• Maintain traceable validation records across lifecycle.
• Identify deviations and coordinate corrective actions.

Skills

Communication

Organisation

Troubleshooting

Stakeholder management

GMP knowledge

QA methodologies

Documentation practices

Data integrity

Change control

Technical writing

Education

Bachelor’s degree in Automation/Electrical/Electronic Engineering or related discipline

Tools

Siemens PLC

Rockwell PLC

HMI systems

Job description

Coalesce Management Consulting is seeking an Automation & Computer System Validation Engineer for a leading healthcare and biopharma client in Singapore. You will support lifecycle management, commissioning, qualification and validation of automated equipment and computerised systems in a GMP manufacturing environment.

You will collaborate with Engineering, Quality Assurance, Manufacturing and vendors to ensure systems are specified, tested and maintained in a validated state across their