Automation Engineer – Computer Systems Compliance | 9-Month Contract

Automation Engineer – Computer Systems Compliance | 9-Month Contract

📍 Location: Joo Koon
📄 Contract: 9 Months
🏭 Environment: GMP / Sterile Manufacturing

🌟 Automation + GMP Compliance Opportunity

We are looking for an Automation Engineer to support the compliance, reliability and lifecycle management of computerized automation systems used in sterile manufacturing operations.

This role is ideal for engineers with exposure to PLC / HMI / SCADA systems, GMP computerized systems, validation and CSV/CSA activities who want to deepen their experience in a highly regulated manufacturing environment.

🔧 What You'll Be Doing

Computer Systems Compliance

• Ensure GMP computerized systems remain compliant throughout their operational lifecycle
• Perform user access management, scheduled alarm reviews and audit trail reviews
• Conduct periodic system reviews and data backup / restoration verification
• Review system logs and security events where applicable
• Maintain complete and compliant documentation for CSC activities

📋 Quality & Compliance

• Initiate, investigate and manage Deviations, Change Controls and CAPAs related to computerized systems
• Perform impact and risk assessments for system changes
• Support regulatory inspections, internal audits, customer audits and quality assessments
• Ensure compliance with Data Integrity and ALCOA+ principles
• Support electronic records, electronic signatures, audit trails and security controls

⚙️ Automation Systems

• Provide technical support for Rockwell Automation and Siemens PLC, HMI and SCADA systems
• Support virtualization (VM) applications and computerized manufacturing systems
• Support systems used across formulation, washing, sterilization, aseptic filling, HVAC, fill-finish and secondary packaging operations
• Monitor system performance and identify opportunities for reliability and lifecycle improvements

🧪 Validation & Qualification

• Participate in qualification, validation and periodic review activities for GMP computerized systems
• Support commissioning and validation of new computerized systems
• Develop and review Validation Plans, Risk Assessments, IQ/OQ protocols, Traceability Matrices and Validation Summary Reports
• Execute validation testing in accordance with GAMP 5, CSA principles and site procedures
• Review vendor documentation and FAT/SAT documentation
• Ensure computerized systems remain in a validated state throughout their lifecycle

🔐 Cybersecurity & Lifecycle Management

• Support cybersecurity controls for GMP automation systems
• Assist with account management, patch coordination and antivirus compliance
• Support backup validation and disaster recovery testing
• Assist with system hardening and continuous improvement initiatives

🏭 Systems & Equipment Exposure

The role supports computerized automation systems associated with:

• Vial washers
• Sterilisation / dehydrogenation tunnels
• Aseptic filling and capping machines
• Tray loading systems
• HVAC / Building Management Systems
• Steam sterilizers / autoclaves
• Parts washers
• Formulation and compounding equipment
• Fill-finish manufacturing equipment
• Secondary packaging machines
• PLC, HMI, SCADA, historian and supervisory control systems

Interested candidates, please send your updated CV to [email protected] or Telegram @jocelynchan

Jocelyn Chan | Consultant
Recruit Express Pte Ltd
EA Licence No.: 99C4599
Personnel EA Licence: R1331820