Job Title- Computer System Validation (CSV) Engineer – Capital Projects
Mode- Hybrid
Duration- 2 years
We are seeking a highly skilled
Computer System Validation (CSV) Engineer
to play a pivotal role in delivering complex capital projects supporting next-generation manufacturing operations.
This is a
long-term contract opportunity (2 years)
within a high-impact digital program, offering outstanding exposure to advanced automation systems, paperless validation, and global regulatory standards.
Role Overview:
You will lead
Computer System Validation activities
across major capital projects. You will collaborate with
Digital, Automation, IT, and Vendor teams
, ensuring systems fully comply with
regulatory, data integrity, and GAMP5 standards
.
Key Responsibilities:
* Act as the
CSV Subject Matter Expert (SME)
for capital project teams
* Develop and maintain
Qualification Plans, Test Plans
, and validation strategies
* Lead the preparation and control of all
SDLC validation deliverables
, including:
* Requirements Specifications
* Functional & Design Specifications
* Requirements Traceability Matrices (RTM)
* Code Reviews
* Test Specifications & Scripts
* Ensure all deliverables comply with
global quality and validation standards
* Provide
FAT oversight and leveraging assessments
* Review and approve all
SDLC documentation
* Partner closely with
Digital Data & Quality teams
to ensure data integrity compliance
* Support
project schedules, validation trackers, and documentation control
* Work directly with
vendors, system integrators, and internal stakeholders
* Represent
CSV in automation, IT, and project meetings
Experience, Skills & Qualifications:
Mandatory:
* Minimum 5 years' experience in CSV within Life Sciences / Pharmaceutical Manufacturing.
* Expert knowledge of GAMP5.
* Hands-on experience with Emerson DeltaV (essential).
* Strong experience across
SDLC and validation lifecycle.
* Fluent English
– written & verbal
* Proficient in
MS Excel, SharePoint, Word & PowerPoint
* Degree in Computer Science, Engineering, or equivalent.
Highly Advantageous
* Experience with
DCS, Siemens PLC/SCADA, OSISoft PI, Werum PAS-X
* Previous experience on
large capital automation projects
* Experience with
paperless validation systems (e.g., Kneat)