Avacone

Specialised IT and regulatory engineering services

Qualification Lead - IT/OT

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeIndianapolis, IN, USANo salary listed

About the Job

Requirements

Strong computerized system validation and commissioning, qualification, and validation experience.
Experience in GMP-regulated pharmaceutical manufacturing.
Knowledge of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
Experience with programmable logic controllers, supervisory control and data acquisition, distributed control systems, manufacturing execution systems, historians, and IT/OT systems.

Responsibilities

Qualify IT/OT systems according to the Customer Quality Manual.
Author, execute, and review user requirement specifications, functional specifications, installation qualification, operational qualification, and test protocols in Kneat.
Perform test execution, troubleshooting, and defect resolution.
Review supplier deliverables and verify compliance with customer requirements.
Coordinate with quality assurance, project control management, IT/OT teams, and suppliers.
Participate in factory acceptance testing, site acceptance testing, commissioning, and startup activities.
Author, review, and/or approve validation and qualification deliverables according to customer procedures.
Lead project test resources in validation and qualification activities.
Act as the project quality representative for testing activities, engaging with local site quality assurance and/or QA eCPL.
Report the status of quality-related activities to key stakeholders.
Engage with suppliers to advise on completing supplier-provided validation and qualification deliverables.

Desired Qualifications

Hands-on installation qualification, operational qualification, and performance qualification execution, and factory acceptance testing/site acceptance testing support.
Experience using Kneat, ValGenesis, Veeva Vault, TrackWise, ServiceNow, or similar validation platforms.

Qualification Lead - IT/OT

Avacone · Indianapolis, United States (Hybrid) · Contract · Posted 2026-11-04

Workplace: hybrid

Department: USA

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.

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About the Company

Avacone

Specialised IT and regulatory engineering services

Avacone is a Swiss service provider offering specialized IT and non-IT solutions for both regulated and non-regulated industries, with a focus on pharmaceuticals, chemicals, medical technology and IT system engineering. It conducts projects worldwide through an integrated, partner-focused model built on two pillars: Pharmaceutical Engineering and IT System Support and Engineering, covering processes, GMP, quality, laboratory operations, IT infrastructure, and related services. The company differentiates itself by turning technological developments into practical, industry-relevant solutions via a globally connected delivery network and by working as an integrated partner aligned with a client’s vision and priorities. Its goal is to help clients achieve compliant, reliable, and scalable operations across complex environments through deep expertise and end-to-end service delivery.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Gemeinde Deutschkreutz, Austria
Founded: 2014

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