Main Responsibilities:
- Assist System Owner for PI system administration at ASM and ensure the reliability of the systems. Maintain the plant control systems under strict GMP change control to optimize System processes and maintain compliance.
- AVEVA PI System AF, Historian, PI Vision, SQL and PI (OPC, EMDVB, MES) various interface experience.
- First point of contact in event of a Shop Floor for PI System/Server related incident. Client based ServiceNow ticketing system. Demand Response based on SLA Levels.
- DeltaV Administration support, Preventive maintenance activities for DeltaV System.
- System Monitoring / Resolution, System Maintenance, System Break/Fix & Outage notification/Management.
- Data Integrity & Audit prep and defense (Support)
- Periodic Review of System Administration SOPs, GMP Periodic review (2/3 Years once), Annual Audit Trail review and Annual User Access Review) for the system.
- Knowledge about the DeltaV DCS System and Virtual Machines Administration.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Lead or support troubleshooting efforts with cross-functional teams to determine root cause and to develop appropriate corrective actions to prevent recurrence.
- Accountable for application compliance, user administration, Disaster Recovery, OS & Application Patching.
- Advancement and maintenance of cyber security controls for manufacturing systems.
- Any other ad hoc duties assigned by the supervisors.
Competencies/ Skills:
- In-depth knowledge of Part 11/Annex 11 computer system, data integrity and validation processes, requirements, and policies.
- Knowledge and experience in application of risk-based approaches to computer validation.
- In-depth knowledge of enterprise cyber resilience and implementing cyber security controls.
- AVEVA PI System knowledge about the PI System Standard Architecture. Preferred AVEVA PI System Admin training courses completed.
- Knowledge and mastery of troubleshooting and process improvement processes.
Preferred Qualifications:
- Experience with installation, administration, and troubleshooting computer data networks and servers is preferred.
- Strong system background and knowledge in both computer system setup including virtualization, hardware, and software.
- Experience supporting information interfaces, data conversion and network infrastructure.
- Prior experience of pharmaceutical/biotech processes and requirements (Part 11 / Annex 11)
- Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards.
- Define, measure, and improve system performance based on tangible metrics.
Interested applicants, please email your resume to Surin Su Sandar Win
Email: surin@recruitexpress.com.sg
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