GMP CSV Validation Engineer - DeltaV Specialist

Source Group International; Oberwallis; On-site; CHF 120,000 - 180,000; Full time

Job summary

Source Group International in Switzerland is seeking an experienced CSV professional to lead risk-based validation gap assessments for GMP pharma/biotech OT systems. You will design system-specific validation strategies, perform risk analyses, create traceability and test documentation, and deliver validated state reports.

Travel to Visp up to 2 days per month is required; fluent English is essential. Nice-to-have: ISA-88/95, Kneat, ValGenesis, FDA inspection exposure, and German language

Qualifications

• 8+ years of CSV in GMP pharma/biotech with OT/automation experience.
• Hands-on validation of DeltaV systems; full lifecycle documentation.
• Strong knowledge of GAMP 5, 21 CFR Part 11 and EU GMP Annex 11.
• Willing to travel to Visp 2 days per month; fluent English.
• Nice-to-have: ISA-88/ISA-95, Kneat, ValGenesis, FDA inspection experience, German.

Responsibilities

• Reconcile system inventory, intended use, GxP impact, ownership and validation status.
• Develop system-specific validation strategies, requirements, risk assessments, traceability, tests and reports proportionate to critical functionality.
• Assess DeltaV batch, historian, PLC/SCADA and interface controls where in scope, with application SMEs.
• Execute or coordinate approved testing, manage discrepancies, and verify validated state after changes.
• Assemble inspection-retrievable lifecycle packages without backdating or substituting reconstructed documents for original evidence.

Skills

CSV depth

DeltaV validation

GAMP 5

Part 11 familiarity

CSA risk concepts

Travel readiness

English fluency

Tools

Kneat

ValGenesis

DeltaV system

Job description

Source Group International in Switzerland is seeking an experienced CSV professional to lead risk-based validation gap assessments for GMP pharma/biotech OT systems. You will design system-specific validation strategies, perform risk analyses, create traceability and test documentation, and deliver validated state reports.

Travel to Visp up to 2 days per month is required; fluent English is essential. Nice-to-have: ISA-88/95, Kneat, ValGenesis, FDA inspection exposure, and German language