CSV Engineer (Delta V)

QCS Staffing; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

QCS Staffing is recruiting for a CSV Engineer (DeltaV) in Singapore on a 24-month contract within the Life Sciences sector. You will plan, execute, and manage CSV activities for DeltaV systems, ensuring lifecycle compliance and traceability from requirements through testing and reporting.

The role requires extensive hands-on DeltaV CSV experience, validated within GMP environments, and a solid understanding of GAMP 5, 21 CFR Part 11, and Data Integrity principles.

Qualifications

• Extensive hands-on DeltaV CSV experience and qualification of DeltaV hardware and software.
• Strong validation experience in regulated pharma/biotech environments.
• Solid understanding of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP, and Data Integrity.
• Experience authoring and reviewing validation deliverables and cross-functional collaboration.

Responsibilities

• Plan, execute, and manage CSV activities for DeltaV systems across validation lifecycle.
• Qualify DeltaV hardware/software components including hardware, control modules, and networks.
• Develop and execute IQ, OQ, PQ, FAT, SAT, and regression testing with full traceability.
• Support audit trails, electronic signatures, access controls, and cybersecurity in GMP environments.

Skills

DeltaV CSV

Validation

GAMP 5

FDA 21 CFR Part 11

EU Annex 11

Data Integrity

Quality Assurance

Tools

DeltaV hardware

IQ/OQ/PQ protocols

Job description

CSV Engineer (Delta V) – Singapore – 24-Month Contract – Life Sciences

How would you like the opportunity to support one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you!

Our client is currently seeking the skills of a CSV Engineer to support their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

What You’ll Deliver

• Plan, execute, and manage Computer System Validation (CSV) activities for DeltaV systems, including validation strategy, risk assessments, traceability, and lifecycle compliance.
• Qualify DeltaV hardware and software, including Professional Plus, operator/application stations, controllers, CIOCs, I/O systems, networks, virtual environments, control modules, equipment modules, batch recipes, alarms, and graphics.
• Develop and execute IQ, OQ, PQ, FAT, SAT, and regression testing while ensuring complete traceability from requirements through testing and final validation reporting.
• Verify audit trails, electronic signatures, user access controls, backup/restore functionality, security configurations, and support cybersecurity, change control, and deviation management activities in regulated GMP environments.

Experience required:

• Extensive hands‑on DeltaV CSV experience, including qualification of DeltaV hardware infrastructure and software applications.
• Strong validation experience within regulated pharmaceutical or biotechnology manufacturing environments.
• Strong understanding of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP principles, and Data Integrity requirements.
• Proven experience authoring and reviewing validation deliverables (URS, FS, DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols and reports) and collaborating with Automation, CQV, Quality, IT, Manufacturing, and vendor teams.