CSV Engineer – DeltaV (pharmaceutical)

KINGSFORCE MANAGEMENT SERVICES PTE LTD; Singapore; On-site; SGD 89,280 - 122,760; Full time

Job summary

KINGSFORCE MANAGEMENT SERVICES PTE LTD is seeking an experienced DeltaV CSV professional for a contract role in Tuas, Singapore. The candidate will plan, execute and manage CSV lifecycle activities, including IQ/OQ/PQ protocols, validation documentation and system qualification.

The role requires hands-on DeltaV hardware/software qualification, MES/OSI PI Historian integration exposure, and strong knowledge of GMP Data Integrity, regulatory requirements and change control processes.

Qualifications

• Bachelor’s degree in a technical discipline.
• Minimum 5 years of DeltaV CSV experience in regulated life sciences.
• Experience qualifying DeltaV hardware and software modules.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and GMP Data Integrity.
• Hands-on IQ/OQ/PQ protocol preparation and execution.
• Experience with FAT/SAT/commissioning and change control processes.
• DeltaV integration with MES and OSI PI Historian is a plus.
• Strong documentation, analytical and communication skills.

Responsibilities

• Plan, execute and manage CSV lifecycle activities for DeltaV.
• Prepare, review and execute validation documentation (URS, FS, DS, IQ/OQ/PQ).
• Qualify DeltaV hardware infrastructure and related components.
• Validate DeltaV software configurations, security settings and functionality.
• Review and test modules, recipes, alarms and graphics.
• Execute IQ, OQ, PQ, FAT, SAT, commissioning and regression testing.
• Support MES and OSI PI Historian integration activities.
• Ensure GMP Data Integrity, audit trails, access control and time sync.
• Support cybersecurity and system hardening; manage deviations and change controls.
• Participate in design reviews, risk assessments and cross-functional reviews.

Skills

DeltaV CSV

Validation documentation

GMP Data Integrity

GAMP 5

FDA 21 CFR Part 11

OSI PI Historian integration

Cross-functional collaboration

Documentation skills

Education

Bachelor’s Degree in Engineering/CS/Automation

Tools

DeltaV hardware

OSI PI Historian

Siemens SIMATIC/WinCC

PLC/HMI qualification

Job description

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.