CSV Consultant – DeltaV Systems

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; Vor Ort; SGD 90.000 - 120.000; Vollzeit

Zusammenfassung

AMTSOL, a leader in life science manufacturing technology solutions, seeks a CSV Consultant with 3-6 years' experience to support GxP-compliant DeltaV systems in pharmaceutical manufacturing environments.

You will perform CSV activities across the system lifecycle (URS, IQ/OQ/PQ, traceability) and collaborate with Automation, Quality, and IT teams to ensure compliant delivery and lifecycle management.

Qualifikationen

• 3-6 years of hands-on experience in CSV within GxP-regulated environments.
• Fundamental understanding of Emerson DeltaV systems, including: control logic and configuration; batch concepts (ISA-88 awareness); user access, security roles, and audit trails.
• Experience with regulated system validation documentation and execution.
• Good understanding of 21 CFR Part 11, data integrity, and system security principles.
• Exposure to GMP pharmaceutical manufacturing operations.

Aufgaben

• Execute CSV activities across the system lifecycle (URS, RA, IQ, OQ, PQ, Traceability, Validation Reports).
• Support validation of DeltaV DCS systems, including configuration verification and functional testing.
• Review and verify control logic, batch configuration, and alarm management from a CSV perspective.
• Validate user access management, roles, security settings, and login controls in DeltaV.
• Support change control, deviation handling, and impact assessments for system updates.
• Participate in risk-based validation aligned with GAMP 5 and site CSV standards.
• Collaborate with Automation and Quality teams during testing, execution, and audits.
• Support regulatory inspections and internal audits as required.

Kenntnisse

CSV (GxP) experience

Regulatory compliance

GAMP 5 awareness

Ausbildung

Bachelor's degree in Engineering, Computer Science, or a related technical discipline

Tools

DeltaV

Jobbeschreibung

A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.

CSV Consultant - DeltaV Systems (3-6 Years)
Industry: Pharmaceutical / Biotech / Life Sciences
Experience: 3-6 Years
Engagement: Contract / Full-Time
Location: Site-based

Role Overview

We are seeking a CSV Consultant with 3-6 years of experience to support GxP-compliant DeltaV systems within pharmaceutical manufacturing environments. The role focuses on computer system validation (CSV) activities with a strong foundational understanding of DeltaV control systems, including configuration, control logic, user access, and security. The consultant will work closely with Automation, Quality, and IT teams to ensure compliant system delivery and lifecycle management.

Key Responsibilities

• Execute CSV activities across the system lifecycle (URS, RA, IQ, OQ, PQ, Traceability, Validation Reports).
• Support validation of DeltaV DCS systems, including configuration verification and functional testing.
• Review and verify control logic, batch configuration, and alarm management from a CSV perspective.
• Validate user access management, roles, security settings, and login controls in DeltaV.
• Support change control, deviation handling, and impact assessments for system updates.
• Participate in risk-based validation aligned with GAMP 5 and site CSV standards.
• Collaborate with Automation and Quality teams during testing, execution, and audits.
• Support regulatory inspections and internal audits as required.

Required Qualifications & Experience

• Bachelors degree in Engineering, Computer Science, or a related technical discipline.
• 3-6 years of hands-on experience in CSV within GxP-regulated environments.
• Fundamental understanding of Emerson DeltaV systems, including:
  • Control logic and configuration
  • Batch concepts (ISA-88 awareness)
  • User access, security roles, and audit trails
• Experience with regulated system validation documentation and execution.
• Good understanding of 21 CFR Part 11, data integrity, and system security principles.
• Exposure to GMP pharmaceutical manufacturing operations.