Senior CSV Engineer (DeltaV)

ONE STOP MANAGEMENT SERVICES PRIVATE LIMITED; Singapore; On-site; SGD 75,000 - 95,000; Full time

Job summary

A technology services provider in Singapore seeks an experienced professional to lead Computer System Validation (CSV) activities for DeltaV automation systems in pharmaceutical manufacturing. Responsibilities include reviewing specifications, preparing and executing validation protocols, and ensuring compliance with regulatory requirements. The ideal candidate has at least 5 years of experience in CSV, particularly with DeltaV version 15. Immediate availability and 6-month rolling contract are mandatory.

Qualifications

• Minimum 5 years hands-on CSV experience in pharmaceutical or biotechnology.
• In-depth experience with DeltaV version 15 (architecture, validation).
• Proven track record of reviewing DeltaV FS/DS and executing protocols.

Responsibilities

• Lead end-to-end CSV activities for DeltaV automation systems.
• Review and approve DeltaV Functional and Design Specifications.
• Prepare, execute, and approve validation protocols.

Skills

Computer System Validation (CSV)

DeltaV version 15

GMP compliance

GAMP 5 knowledge

Data integrity principles

Experience with automated process controls

Job description

Job Description & Requirements

Job Purpose

To lead and execute end-to-end Computer System Validation (CSV) activities for DeltaV automation systems in pharmaceutical manufacturing, ensuring full compliance with GMP, 21 CFR Part 11, EU Annex 11, and PIC/S requirements.

Key Responsibilities

DeltaV Validation Lifecycle Leadership

Review and approve DeltaV Functional Specification (FS) and Design Specification (DS) for GMP‑critical systems.

Prepare, execute, and approve validation protocols:

• Software Installation Qualification (SIQ)
• Input/Output (I/O) Loop Check Protocols
• Functional/Design Qualification (FQ/DQ) as required

Conduct pre‑execution and post‑execution reviews of all CSV protocols.

Compliance & Documentation

Approve automation change controls, including risk assessments (GAMP 5, FMEA).

Ensure adherence to data integrity principles and electronic record/electronic signature (ERES) requirements.

Maintain validation documentation in alignment with site SOPs and regulatory standards.

Skills & Experience

Minimum 5 years hands‑on CSV experience in pharmaceutical or biotechnology environments.

In‑depth experience with DeltaV version 15 (architecture, configuration, and validation).

Proven track record of reviewing/approving DeltaV FS/DS and executing IQ/OQ/PQ protocols.

Strong knowledge of GAMP 5, 21 CFR Part 11, and PIC/S guidelines.

Experience with automated process controls (bioreactors, chromatography, filling lines) is highly preferred.

Must be available immediately

6 Months contract (Rolling contract)

Must familiar with deltaV version 15, review/approve DeltaV function specification/design specification, prepare protocols, review/approve pre/post execution protocols (input/output loop check protocols), pre-post review/approve software installation qualification protocols, approve automation change control etc. (minimum 5 years relevant experience)