Qualification Lead - IT/OT

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

Qualification Lead Role:

• Primary focus is to ensure that the qualification of the OT system, quality management for IT and OT systems, ensuring that the required validation / qualification deliverables are implemented according to the Customer Quality Manual and the relevant regulatory requirements
• According to the Customer procedures, author, review and/or approve various validation / qualification deliverables
• Review / approve validation / qualification deliverables as provided by the supplier of the relevant system(s), ensure that such deliverables are compliant to the Customer requirements
• Lead the project test resources in relation to the validation / qualifications related activities of the project
• Act as the project’s quality representative in relation to testing activities, engaging with local site QA and/or QA eCPL
• Report on the status of the various quality-related activities for key stakeholders
• Engagement with the suppliers to advise the suppliers on the suitable completion of supplier provisioned validation / qualification deliverables.

Required Validation Activities

• 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, ITOT teams and suppliers.
• Participate in FAT, SAT, commissioning and startup activities.

Desired Experience Profile

The candidate profiles proposed for this RFP emphasize:

• Strong CSV/CQV experience.
• GMP-regulated pharmaceutical manufacturing background.
• GAMP 5, EU GMP Annex 11, 21 CFR Part 11 knowledge.
• 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.