Validation Engineer| Pharmaceutical |Indianapolis,IN | H1B | vyshnavi@spruceinfotech.com

[vyshnavi C2C]

Roles and Responsibilities

• Provide application/system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment.
• Lead OT system qualification and validation, including PAS/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.

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Mandatory Skills

• 8–9 years of relevant experience in CSV/IT Quality & Compliance within the Life Sciences industry.
• Expertise in OT system qualification/validation, especially:
• PAS/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.

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Desired Skills

• OT system qualification in Radio Ligand Therapy or critical dosage forms.
• PAS/DCS qualification with integration experience.
• Knowledge of MES, QMS (TrackWise), LIMS, Empower CDS, Chromeleon, Business Analytics, Middleware systems.
• Experience with OT Security requirements in regulated environments.

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Nice to Have Skills

• Hands-on experience with testing/validation tools such as:
• HP ALM
• Kneat
• ServiceNow (SNOW)