About our client: Our client is a leading global pharmaceutical company.
About the role:
- Plan, execute and manage DeltaV Computer System Validation (CSV) lifecycle activities.
- Prepare, review and execute validation documentation including URS, FS, DS, Risk Assessments, Traceability Matrix, IQ, OQ, PQ protocols and Validation Reports.
- Perform qualification of DeltaV hardware infrastructure, including Professional Plus, Application & Operator Stations, M-Series/S-Series/PK Controllers, CIOCs, I/O systems, network components and virtual environments.
- Validate DeltaV software applications, system configurations, security settings and functionality.
- Review and test Control Modules (CM), Equipment Modules (EM), Unit Modules, Batch Phases, Recipes, Alarms, Interlocks and Graphics.
- Execute and support IQ, OQ, PQ, FAT, SAT, commissioning and regression testing activities.
- Support integration activities involving MES and OSI PI Historian systems.
- Ensure compliance with GMP Data Integrity requirements, audit trails, user access management, security roles, electronic signatures, backup and restore functionality and time synchronization.
- Support cybersecurity and system hardening activities for validated systems.
- Manage deviations, discrepancies, change controls and validation deliverables.
- Participate in design reviews, risk assessments, FAT/SAT activities and change control reviews.
- Collaborate with Automation, CQV, Quality, IT, Manufacturing teams and external vendors throughout the project lifecycle.
About you:
- Bachelor's Degree in Engineering, Computer Science, Automation, Instrumentation, Pharmaceutical Technology or a related technical discipline.
- Minimum 5 years of experience in DeltaV Computer System Validation (CSV) within regulated pharmaceutical, biotechnology or life sciences environments.
- Proven experience in qualifying DeltaV hardware infrastructure and software modules.
- Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and GMP Data Integrity requirements.
- Hands-on experience in preparing and executing IQ, OQ and PQ protocols and validation documentation.
- Experience with FAT, SAT, commissioning and change control processes.
- Experience with DeltaV integration involving MES and OSI PI Historian will be an advantage.
- Experience in CSV qualification of PLC/HMI-based systems such as Siemens SIMATIC/WinCC, SCADA systems or Siemens SIMATIC Logon will be desirable.
- Strong documentation, analytical and communication skills with the ability to work independently and collaborate effectively with cross-functional teams.
Other:
- Employment Type: Contract
- Work Schedule: 5 days per week
- Location: Tuas, Singapore
.Please note that only shortlisted candidates will be contacted..
Employment Agency: Kingsforce Management Services Pte. Ltd.
Employment Agency Licence No: 94C3545
EA Personnel: Kimberly Wong
EA Personnel Reg. No.: R1984508
