CSV Engineer – DeltaV (Pharmaceutical) - Part-Time

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