Automation Engineer – Computer Systems Compliance | 9-Month Contract #HMS

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 60,000 - 90,000; Part time

Job summary

Recruit Express Pte Ltd is seeking an Automation Engineer to support GMP-computerized systems in sterile manufacturing under a 9-month contract. Based in Joo Koon, you will handle compliance, reliability and lifecycle management of automation systems.

The role emphasizes PLC/HMI/SCADA, validation and CSV/CSA activities to thrive in a highly regulated environment.

Qualifications

• Qualification, validation and periodic review of GMP computerized systems.
• Develop IQ/OQ protocols and validation summary reports.
• Review vendor FAT/SAT documentation.
• Ensure systems stay validated throughout lifecycle.

Responsibilities

• Provide technical support for Rockwell and Siemens PLC/HMI/SCADA systems.
• Support virtualization and computerized manufacturing systems.
• Monitor system performance for reliability and lifecycle improvements.
• Assist with cybersecurity controls and patch coordination.

Skills

PLC

HMI

SCADA

GMP compliance

Validation

CSV/CSA

Cybersecurity controls

Rockwell Automation

Siemens PLC

VM / virtualization

Tools

Rockwell Automation

Siemens PLC

HMI/SCADA software

Job description

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
• Conduct 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

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