Automation Engineer – Computer Systems Compliance, 9-month, Joo Koon

Job Summary:

• Automation Engineer role within sterile pharmaceutical manufacturing, looking after GMP computerized automation systems such as PLC, HMI and SCADA. They need someone technically hands-on with Rockwell and/or Siemens, but who also understands CSV, GAMP 5, validation, data integrity and GMP compliance

Job Scope:

• Ensure the continued compliance of GMP computerized systems throughout their operational lifecycle in accordance with approved site procedures, global quality standards, and regulatory requirements.
• Execute routine Computer Systems Compliance (CSC) activities, including:
• User access management (creation, modification, periodic review, and deactivation of user accounts).
• Scheduled alarm reviews.
• Audit trail reviews in accordance with approved procedures.
• Computerized system periodic reviews.
• Data backup verification, restoration testing, and data retrieval activities.
• Review of system logs and security events, where applicable.
• Maintain complete, accurate, and compliant documentation for all Computer Systems Compliance activities.
• Initiate, investigate, and manage Deviations, Change Controls, and Corrective and Preventive Actions (CAPAs) related to computerized systems, ensuring timely implementation and effectiveness verification.
• Perform impact and risk assessments for changes affecting computerized systems and ensure compliance with change management procedures.
• Support regulatory inspections, internal audits, customer audits, and quality assessments by providing documentation and technical expertise related to computerized systems.
• Ensure compliance with Data Integrity requirements, including ALCOA+ principles, electronic records, electronic signatures, audit trail management, and security controls.
• Collaborate with Quality Assurance, Manufacturing, Validation, Engineering, IT, and Equipment Vendors to maintain the validated state of computerized systems.
• Participate in qualification, validation, and periodic review activities for GMP computerized systems in accordance with GAMP 5 and company validation standards.
• Monitor system performance and identify opportunities for continuous improvement, cybersecurity enhancements, and lifecycle optimization

Equipment and Systems Supported:

• Provide Computer Systems Compliance support for sterile manufacturing process equipment, including but not limited to:
• IMA internal and external vial washers, Dehydrogenation and sterilization tunnels, Aseptic filling machines, Capping machines, Tray loading systems, HVAC and Building Management Systems (BMS), Steam sterilizers (Autoclaves), Parts washers, Formulation and compounding equipment, Fill-finish manufacturing equipment, Secondary packaging machines, associated PLC, HMI, SCADA, historian, and supervisory control systems supporting GMP manufacturing operations.
• Support commissioning, qualification, and validation of new computerized systems.
• Develop and review Validation Plans (VP), Risk Assessments, IQ/OQ protocols, Traceability Matrix, and Validation Summary Reports.
• Execute validation testing in accordance with GAMP 5, CSA principles, and site validation procedures.
• Review vendor documentation and Factory/Site Acceptance Test (FAT/SAT) documentation.
• Ensure computerized systems remain in a validated state throughout their lifecycle.
• Support implementation of cybersecurity controls including account management, patch coordination, antivirus compliance, backup validation, disaster recovery testing, and system hardening for GMP automation systems.

Requirements:

• Bachelor's degree in Automation Engineering, Electrical & Electronics Engineering, Instrumentation Engineering, Computer Engineering, or a related engineering discipline
• 5 to 8 years of proven experience in the maintenance of process equipment, preferably in a Pharma manufacturing facility
• Hands-on experience with PLC/SCADA sterile manufacturing equipment is required
• Good understanding of equipment validation, GMP requirements, and maintenance practices in a regulated manufacturing environment
• Experience with Maximo, TrackWise, and Kneat is good to have
• Able to work effectively in a fast-paced and highly regulated environment
• Ability to plan, schedule, organize, prioritize, and coordinate maintenance and project activities
• Good understanding of production processes and related validation, GMP, and compliance requirements
• Troubleshooting skills with good knowledge of Root Cause Analysis tools and problem-solving methodologies
• Rockwell FactoryTalk , Siemens TIA Portal, Wincc, Historian systems, Active Directory
• Good communication, coordination, and documentation skills

Additional Information:

• Salary – S$400 per day
• Contract duration: 9-month contract, potential renewal
• Commencement Date: Immediate
• Working days and hours: Monday to Friday, 8am to 5.20pm
• Location: Joo Koon, company bus pick-up