CSV Engineer

SGI; Oberwallis; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Tools

Kneat

ValGenesis

Jobbeschreibung

• Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.

Purpose

• Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.

Revised 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.

Must-have requirements (recruitment)

• 8+ years of CSV in GMP pharma/biotech (or 5+ with substantial OT/automation CSV depth), with substantial experience on OT/automation systems (DCS, SCADA, PLC).
• Hands-on validation of DeltaV systems; full lifecycle authoring and execution (plan to summary report).
• Strong working knowledge of GAMP 5 (Second Edition), 21 CFR Part 11, EU GMP Annex 11 and risk-based assurance (CSA) principles.
• Willing and able to travel to Visp 2 days per month. Fluent English.
• Nice-to-have: ISA-88/ISA-95, electronic validation tools (Kneat, ValGenesis), FDA inspection experience, German.
• CV keywords: CSV, DeltaV validation, GAMP 5 Second Edition, Part 11, Annex 11, CSA, traceability matrix, Kneat, ValGenesis, ISA-88.

Critical competencies

• GMP automation CSV including hands-on DeltaV validation; 8+ years or equivalent demonstrated depth (thresholds under D09).
• GAMP 5 second edition, EU GMP Annex 11/15, relevant Part 11 and GMP electronic-record controls.
• Risk-based test design, batch/recipe/interface controls, deviation management and retrospective gap remediation.
• Clear distinction between FDA CSA guidance for medical-device production/QMS software and applicable pharmaceutical GMP expectations.

CV screening knock-out criteria (screening w/c 19-Oct-2026)

• No OT/automation CSV experience (IT/business-system-only profiles do not qualify).
• No GMP-regulated industry experience.
• Not available to start on 1-Dec-2026, or unable to travel to Visp 2 days per month.

Minimum deliverables

• Approved system-level validation gap assessment and prioritized remediation plan.
• Risk assessments, traceability, approved test protocols/results and validation summary reports for assigned systems.
• Deviation/exception register with disposition and residual-risk statements.

We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.