Senior CSV Engineer: Pharma Automation Validation Lead

XOT SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

XOT SOLUTIONS PTE. LTD. seeks a Senior CSV Engineer to lead validation across automation IT/OT systems in pharmaceutical manufacturing. You will own end-to-end validation activities, ensuring lifecycle coverage from concept through retirement, aligned with global regulatory guidelines and GAMP 5.

Responsibilities include authoring validation documents, managing risk, overseeing testing, and coordinating with vendors to uphold data integrity and compliant system operation.

Qualifications

• Bachelor's degree in Engineering, Computer Science, IT, Life Sciences, or related discipline.
• 5–8 years of direct CSV experience in Pharma/biotech/medical device industries.
• Proven track record validating automated process control systems (Siemens, Emerson DeltaV, Rockwell), SCADA, and MES.

Responsibilities

• Lead end-to-end CSV life cycle (Concept, Project, Operation, Retirement) for manufacturing automation and IT/OT systems.
• Author, review, and approve validation deliverables (VMP, URS, FS, HDS, SDS, RTM, IQ/OQ/PQ, VSR).
• Ensure automated systems comply with FDA 21 CFR Part 11, Annex 11, and HSA guidelines; data integrity (ALCOA+).
• Perform Quality Risk Assessments (QRA) to determine validation strategies per GAMP 5.
• Oversee testing execution, investigate failures, and manage deviations to resolution.
• Collaborate with automation vendors and system integrators; review FAT/SAT docs.
• Drive change control, CAPAs, and periodic system reviews to maintain validation state.
• Provide CSV mentorship to cross-functional teams (Engineering, Manufacturing, IT, Quality).

Skills

Analytical skills

Troubleshooting

Technical writing

Cross-functional collaboration

Project management

Education

Bachelor's degree in Engineering/Computer Science

Job description

XOT SOLUTIONS PTE. LTD. seeks a Senior CSV Engineer to lead validation across automation IT/OT systems in pharmaceutical manufacturing. You will own end-to-end validation activities, ensuring lifecycle coverage from concept through retirement, aligned with global regulatory guidelines and GAMP 5.

Responsibilities include authoring validation documents, managing risk, overseeing testing, and coordinating with vendors to uphold data integrity and compliant system operation.