Senior GMP CSV Engineer - DeltaV Validation & Risk

SGI; Oberwallis; In loco; CHF 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

SGI in Switzerland seeks an experienced CSV validation expert for GMP automation. You will lead risk-based validation gap assessments, develop risk analyses, and author traceability and test reports for DeltaV systems. Travel to Visp (2 days/month) and fluency in English are required.

Responsibilities include executing or coordinating testing, managing discrepancies, and ensuring validated state after changes, while assembling lifecycle packages with original evidence.

Competenze

• 8+ years of CSV experience in GMP pharma/biotech with OT/automation exposure.
• Hands-on DeltaV validation across full lifecycle (plan to summary report).
• Strong knowledge of GAMP 5 Second Edition, Part 11 and EU GMP Annex 11.
• Willing to travel to Visp 2 days/month; fluent English.
• Nice-to-have: ISA-88/ISA-95; FDA inspection experience; German language.
• CV keywords include CSV, DeltaV validation, Kneat, ValGenesis, ISA-88.

Mansioni

• Execute risk-based validation gap assessment and remediation for the OT system inventory.
• Develop validation strategies, risk assessments, traceability, and test reports.
• Validate DeltaV systems; oversee lifecycle documentation.
• Coordinate testing, manage discrepancies, verify validated state after changes.
• Assemble lifecycle packages with original evidence; avoid backdating or reconstruction.

Conoscenze

CSV in GMP pharma/biotech

DeltaV validation

GAMP 5 Second Edition

21 CFR Part 11

EU GMP Annex 11

CSA principles

Risk-based test design

Traceability and documentation

Strumenti

Kneat

ValGenesis

Descrizione del lavoro

SGI in Switzerland seeks an experienced CSV validation expert for GMP automation. You will lead risk-based validation gap assessments, develop risk analyses, and author traceability and test reports for DeltaV systems. Travel to Visp (2 days/month) and fluency in English are required.

Responsibilities include executing or coordinating testing, managing discrepancies, and ensuring validated state after changes, while assembling lifecycle packages with original evidence.