Implementation and delivery AIS automation related system of Singapore Project
Responsibilities :
- Work with the local Site and Global Engineering Leadership, various internal function teams organization, and 3rd party contractors to lead the activities to implement automation solutions for a new clinical/commercial biologics manufacturing facility.
- Drive functional commitment on the project and provide high level of oversight and coordination to seamlessly integrate automation engineering efforts within the site
- Consult with subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.
- Work with technical team and business stakeholders to gather user requirements, developing project charter, timeline,
- milestone and deliverables integrating lifecycle management per GAMP5 Guidance.
- Owns and Monitors automation system projects/program, including activities, resources, costs, roles, responsibilities, and quality, as defined in the Project Management Methodology.
- Manage and coordinate project budgets, forecasts, tasks, plans, risks, change management and status to support effective decision making and project reporting to stakeholders and review boards.
- Organize effective project meeting including steering meeting, promote effective risk and problem management to ensure processes are in place and used effectively
- Plan operations and handovers, including controlled handovers to support and maintenance.
Requirements
- Bachelor’s Degree in engineering
- Minimum 5 years of experience in Project Automation, Instrumentation & Controls
- Experience within the pharmaceutical or biotechnology industry is required
- Strong knowledge of industry standards and regulations, including:
- GAMP 5
- 21 CFR Part 11
- EU Annex 11
- ISA-S88 (Batch Control)
- ISA-S95
- Familiarity with ASTM E2500 methodology is an advantage
- Hands-on experience implementing control systems across:
- DCS, BMS, QBMS, SCADA, HMI, PLC platforms
- Experience with DeltaV and Rockwell Automation systems is preferred