Validation Lead - IT/OT & GMP/CSV Expert

Avacone; Indianapolis (IA); On-site; USD 120,000 - 150,000; Full time

Job summary

Avacone seeks a Qualification Lead to ensure validation and qualification deliverables for IT/OT systems comply with the Customer Quality Manual and regulatory requirements. The role includes authoring, reviewing, and approving URS/FS/IQ/OQ, leading test resources, and coordinating with QA, PCM, IT/OT teams and suppliers during FAT/SAT, commissioning and startup.

Ideal candidates bring strong CSV/CQV experience, GMP background, and hands-on IQ/OQ/PQ execution along with experience using Kneat,

Qualifications

• Must have strong CSV/CQV experience.
• GMP-regulated pharmaceutical manufacturing background.
• Knowledge of GAMP 5, EU GMP Annex 11, 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.

Responsibilities

• Qualify IT/OT systems per Customer Quality Manual.
• Author, execute and review URS, FS, IQ, OQ and test protocols in Kneat.
• Perform test execution, troubleshooting and defect resolution.
• Review supplier deliverables and verify compliance.
• Coordinate with QA, PCM, IT/OT teams and suppliers.
• Participate in FAT, SAT, commissioning and startup activities.

Skills

CSV/CQV

GMP background

GAMP 5 & Part 11

IT/OT systems

IQ/OQ/PQ execution

FAT/SAT support

Tools

Kneat

ValGenesis

Veeva Vault

TrackWise

ServiceNow

Job description

Avacone seeks a Qualification Lead to ensure validation and qualification deliverables for IT/OT systems comply with the Customer Quality Manual and regulatory requirements. The role includes authoring, reviewing, and approving URS/FS/IQ/OQ, leading test resources, and coordinating with QA, PCM, IT/OT teams and suppliers during FAT/SAT, commissioning and startup.

Ideal candidates bring strong CSV/CQV experience, GMP background, and hands-on IQ/OQ/PQ execution along with experience using Kneat,