Qualification Lead – IT/OT

avacone Switzerland

. Ensure qualification of the OT system and quality management for IT and OT systems .

Posted 11/5/2026contractIndianapolis • Iowa • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in validation and qualification of IT/OT systems within GMP-regulated environments, ensuring compliance with relevant regulatory standards and quality management practices. Proficient in authoring and executing validation deliverables, including URS, FS, IQ, OQ, and test protocols.

Highest-signal resume keywords

CSV/CQV ExperienceGMP-Regulated Pharmaceutical ManufacturingKnowledge of GAMP 5Experience with PLC, SCADA, DCS, MESHands-On IQ/OQ/PQ Execution

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation/Qualification DeliverablesTest ExecutionTroubleshootingDefect ResolutionFAT/SAT Support

Soft Skills

Stakeholder ReportingSupplier AdvisingProject Leadership

Tools & Technologies

KneatValGenesisVeeva VaultTrackWiseServiceNow

Industry Keywords

EU GMP Annex 1121 CFR Part 11Quality ManagementIT/OT SystemsCustomer Quality Manual

Tech Stack

Tools & technologies

ServiceNowVault

About the role

Key responsibilities & impact

Ensure qualification of the OT system and quality management for IT and OT systems
Ensure required validation/qualification deliverables are implemented according to the Customer Quality Manual and relevant regulatory requirements
Author, review, and/or approve validation/qualification deliverables
Review and approve supplier validation/qualification deliverables for compliance with Customer requirements
Lead project test resources for validation and qualification activities
Act as the project quality representative for testing activities, engaging with local site QA and/or QA eCPL
Report quality-related activity status to key stakeholders
Advise suppliers on completing supplier-provided validation/qualification deliverables
Qualify IT/OT systems per the Customer Quality Manual
Author, execute, and review URS, FS, IQ, OQ, and test protocols in Kneat
Perform test execution, troubleshooting, and defect resolution
Coordinate with QA, PCM, ITOT teams, and suppliers
Participate in FAT, SAT, commissioning, and startup activities

Requirements

What you’ll need

Strong CSV/CQV experience
GMP-regulated pharmaceutical manufacturing background
Knowledge of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11
Experience with PLC, SCADA, DCS, MES, Historian, and IT/OT systems
Hands-on IQ/OQ/PQ execution and FAT/SAT support
Experience using Kneat, ValGenesis, Veeva Vault, TrackWise, ServiceNow, or similar validation platforms