Qualification Lead - IT/OT

Avacone; Indianapolis (IN); On-site; USD 110,000 - 160,000; Full time

Job summary

Avacone is seeking a Qualification Lead to ensure IT/OT system qualification and quality management in GMP environments. You will author, review, and approve validation deliverables in line with Customer Quality Manual and regulatory requirements.

Lead project test resources, act as quality representative for testing activities, and engage with QA, IT/OT teams and suppliers to ensure compliant deliverables and successful FAT/SAT, commissioning, and startup activities.

Qualifications

• Experience with CSV/CQV validation in GMP environments.
• Strong understanding of regulatory expectations (EU GMP Annex 11, 21 CFR Part 11).
• Ability to author/review validation deliverables (URS, FS, IQ, OQ, PQ).
• Hands-on IQ/OQ/PQ execution and FAT/SAT support.

Responsibilities

• Lead qualification and validation activities for IT/OT systems.
• Coordinate with QA, IT/OT, and suppliers to ensure compliant deliverables.
• Act as project quality representative for testing activities and status reporting.

Skills

CSV/CQV experience

GMP manufacturing

Regulatory knowledge

Quality leadership

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.