Senior Automation Engineer [GMP Compliance | Pharma MNC | $10K] RRKC

Rapid Recruitment Asia Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Rapid Recruitment Asia Pte Ltd is recruiting an Automation Engineer - GMP Compliance to support the reliability, compliance and lifecycle management of computerized automation systems used in sterile pharmaceutical manufacturing.

You will work closely with Engineering, Manufacturing, Quality, Validation, IT and external vendors to ensure automation systems comply with GMP, Data Integrity, EHS and regulatory requirements.

Qualifications

• Bachelor's degree in Automation, Electrical & Electronics, Instrumentation, Computer Engineering or a related engineering discipline.
• 5-8 years of relevant experience in automation, process equipment or maintenance, preferably within pharmaceutical or regulated manufacturing.
• Hands-on experience with PLC/SCADA systems and manufacturing equipment.
• Experience with GMP, equipment validation and computerized systems compliance.

Responsibilities

• Ensure computerized automation systems remain GMP compliant and in a validated state throughout their lifecycle.
• Manage deviations, change controls and CAPAs related to computerized systems.
• Conduct risk and impact assessments for system changes.
• Support qualification, validation and periodic review activities for GMP computerized systems.
• Prepare and review validation documentation such as Risk Assessments, IQ/OQ protocols, Traceability Matrix and Validation Reports.
• Support FAT/SAT activities and review vendor documentation.
• Provide technical support and troubleshooting for Rockwell and Siemens PLC, HMI and SCADA systems.
• Support automation systems used in formulation, sterilization, aseptic filling, HVAC, fill-finish and packaging operations.
• Support cyber-security and system controls, including user access, patching, antivirus, backup and disaster recovery activities.
• Work closely with Quality, Manufacturing, Validation, Engineering, IT and equipment vendors to maintain system compliance.
• Identify opportunities to improve system reliability, compliance and operational efficiency.

Skills

GMP Compliance knowledge

System troubleshooting

Documentation and compliance

Education

Bachelor's degree in Automation, Electrical & Electronics, Instrumentation, Computer Engineering or related engineering discipline

Tools

Rockwell PLC

Siemens PLC

HMI

SCADA

Job description

About the Role

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

You will work closely with Engineering, Manufacturing, Quality, Validation, IT and external vendors to ensure automation systems comply with GMP, Data Integrity, EHS and regulatory requirements.

The role involves hands-on support for PLC, HMI, SCADA and computerized systems, as well as system validation, troubleshooting, compliance reviews and continuous improvement.

Key Responsibilities

• Ensure computerized automation systems remain GMP compliant and in a validated state throughout their lifecycle.




• Manage and support Deviations, Change Controls and CAPAs related to computerized systems.




• Conduct risk and impact assessments for system changes.




• Support qualification, validation and periodic review activities for GMP computerized systems.




• Prepare and review validation documentation such as Risk Assessments, IQ/OQ protocols, Traceability Matrix and Validation Reports.




• Support FAT/SAT activities and review vendor documentation.




• Provide technical support and troubleshooting for Rockwell and Siemens PLC, HMI and SCADA systems.




• Support automation systems used in formulation, sterilization, aseptic filling, HVAC, fill-finish and packaging operations.




• Support cyber-security and system controls, including user access, patching, antivirus, backup and disaster recovery activities.




• Work closely with Quality, Manufacturing, Validation, Engineering, IT and equipment vendors to maintain system compliance.




• Identify opportunities to improve system reliability, compliance and operational efficiency.

Perform routine computerized systems compliance activities, including:

• User access management and periodic reviews


• Alarm and audit trail reviews


• System periodic reviews


• Data backup, restoration and retrieval checks


• System logs and security reviews

Role Requirements

• Bachelor's Degree in Automation, Electrical & Electronics, Instrumentation, Computer Engineering or a related engineering discipline.


• 5-8 years of relevant experience in automation, process equipment or maintenance, preferably within pharmaceutical or regulated manufacturing.


• Hands-on experience with PLC / SCADA systems and manufacturing equipment.


• Experience with GMP, equipment validation and computerized systems compliance.