Validation Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Indianapolis, IN, 46262

Posted Date : 13 October 2025

Job Type : Other

Category : Mechanical Engineering

Occupation : Validation Engineer

Job Details

Responsibilities:

Provide application/system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment.
Lead OT system qualification and validation, including Client/DCS integrated with manufacturing equipment.
Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
Author and review Validation Plans, Test Scripts/Protocols, and Validation Summary Reports.
Ensure alignment with SDLC deliverables and IT Quality Management Systems (IT QMS).
Conduct and manage risk assessments, deviations, investigations, CAPA handling, test management, and compliance activities.
Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP5 guidelines and other regulatory requirements.
Validate Standalone Systems and support ISA95-based manufacturing integration.
Collaborate with Manufacturing, Quality, and Engineering teams to ensure successful validation and compliance.
Consider OT Security requirements during qualification and validation projects.
Contribute to Agile/DevOps-based validation approaches.

Requirements:

8-9 years of relevant experience in CSV/IT Quality & Compliance within the Life Sciences industry.
Expertise in OT system qualification/validation, especially:
Client/DCS systems integrated with manufacturing equipment.
Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
Strong knowledge of Manufacturing, Quality, and Engineering system validations.
Experience with risk management, deviation/defect handling, investigations, CAPA handling, test management & compliance.
Hands-on experience authoring validation documentation (VP, IQ, OQ, PQ, VSR).
Deep understanding of 21 CFR Part 11, EU Annex 11, GAMP5 guidelines.
Familiarity with Standalone and Enterprise system qualifications.
Knowledge of ISA95 architecture for manufacturing operations.
OT system qualification in Radio Ligand Therapy or critical dosage forms.
Client/DCS qualification with integration experience.
Knowledge of MES, QMS (Track Wise), LIMS, Empower CDS, Chrome Leon, Business Analytics, Middleware systems.
Experience with OT Security requirements in regulated environments.

Nice to Have Skills: