Anna Hrehlevych
ConsultantJob Description
- Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.
- 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.
- 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.
- 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.
- 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.
- 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.
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We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.
Source Group International Ltd is acting as an Employment Business in relation to this vacancy