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The AIS Senior Manager will lead the Automation Integration Services function to ensure reliable, compliant, and efficient automation for Drug Substance and Drug Product manufacturing in Singapore. You will drive continuous improvement, digitalization, and regulatory compliance, while building a high-performing automation team to support manufacturing excellence.
Responsibilities include leading operational oversight of process automation systems, ensuring system availability, lifecycle
The AIS Senior Manager is responsible for leading the Automation Integration Services function to ensure reliable, compliant, and efficient operation of site automation systems supporting Drug Substance (DS) and Drug Product (DP) manufacturing. This role provides operational leadership for automation activities, drives continuous improvement and digitalization initiatives, ensures GMP and regulatory compliance, and develops ahigh-performing automation team to support business growth and manufacturing excellence.
1. Provide operational leadership for the AIS organization, establishing and developing ahigh-performing automation team through effective talent development, coaching, succession planning, and performance management.
2. Lead the daily operation, monitoring, maintenance, and lifecycle management of process automation systems supporting DS and DP manufacturing, ensuring high system availability, reliability, and operational efficiency.
3. Ensure all automation operation, maintenance, troubleshooting, and change management activities are executed in accordance with approved SOPs, GMP requirements, Data Integrity principles, and site quality systems.
4. Establish and maintain automation standards, best practices, and performance metrics to improve system reliability and operational excellence.
5. Lead investigation, root cause analysis, and resolution of automation-related issues, ensuring timely closure of deviations, CAPAs, change controls, and configuration changes.
6. Drive digitalization, smart manufacturing, and process optimization initiatives to improve productivity, data visibility, operational efficiency, and manufacturing performance.
7. Ensure automation systems comply with GMP, EHS, Data Integrity, Cybersecurity, GAMP5,and applicable regulatory requirements.
8. Support Computer System Validation (CSV) activities and ensure validated state is maintained throughout the automation system lifecycle.
9. Act as the automation subject matter expert during internal audits, customer audits, corporate audits, and regulatory inspections, supporting audit readiness and timely closure of observations.
10. Partner with Manufacturing, Engineering, Quality, Validation, IT, Utilities, and Project teams to support operational and project objectives.
11. Provide technical leadership for automation projects, including design review, commissioning, qualification, startup, and handover activities.
12. Develop departmental objectives, budgets, resource plans, and long-term capability strategies aligned with site and corporate goals.
13. Perform other duties and responsibilities as assigned by management.