Senior Tech Specialist, Cloud Engineering – R01573611

Brillio; Bengaluru; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Brillio in Bangalore, India, is seeking a Senior Tech Specialist in Cloud Engineering to drive IT governance across the SDLC, ensuring regulatory compliance and robust validation for cloud platforms.

You will lead CSV/CSA activities, IQ/OQ/PQ qualification, and maintain validation documentation while coordinating with QA, IT, and data governance teams. Prioritize GDPR and AI governance integration.

Qualifications

• Experience in IT quality, CSV/CSA, and IT compliance in pharma or life sciences
• Strong knowledge of GxP, 21 CFR Part 11, and EU Annex 11
• Hands-on IQ/OQ/PQ and cloud/SaaS validation
• Proficiency with validation docs, URS, FS/DS, test scripts, and traceability
• Experience with SDLC, change management, release governance
• Familiarity with DocuSign or similar e-signature platforms
• Understanding GDPR, data privacy, deviations, CAPA, and change control
• Awareness of AI governance and risk management requirements

Responsibilities

• Govern IT platform and app governance across SDLC and regulatory compliance
• Plan and execute CSV/CSA activities using GAMP 5 methodologies
• Lead qualification activities for systems, cloud environments, and sandboxes (IQ/OQ/PQ)
• Prepare and review validation docs and reports
• Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11
• Develop and maintain SOPs, work instructions, and system docs
• Manage document review workflows using e-signature platforms
• Coordinate with QA, IT, business owners, security, and data governance teams
• Manage deviations, CAPAs, change controls, and release approvals
• Ensure GDPR/data privacy compliance, including DPIA documentation
• Support AI/GenAI governance, model risk assessments, and monitoring controls
• Assist internal audits and regulatory inspections with validation evidence

Skills

Oracle Integration Cloud

Oracle Cloud Development

Powershell

OpenStack

Informatica ETL

CloudHub/Mule

Cloud Storage

Adobe Creative Cloud

Demandware/Commerce Cloud

CloudForms

Education

Bachelor’s degree in Computer Science, Information Technology, Pharmaceutical Sciences

Tools

ServiceNow

Veeva Vault QualityDocs

DocuSign

MuleSoft

Job description

Senior Tech Specialist, Cloud Engineering - R01573611

Bangalore, India

Infrastructure Engineering Senior Tech Specialist, Cloud Engineering

Primary Skills

• PaaS – Oracle Integration Cloud, Cloud Health, Cloudlets, Powershell, Oracle Cloud Development (API, Data, Integration), Adobe Creative Cloud, Demandware / Commerce Cloud, Cloudcheckr, CloudHub/Mule, Open Stack, Informatica & ETL Tools, CloudForms, Cloud Storage

Specialization

• Cloud Platform consulting: Senior Tech Specialist, Cloud Engineering

Job requirements

• Experience Range: with at least 6 years of experience in IT quality, system validation, and compliance for cloud platforms within the pharmaceutical or life sciences industry Key Responsibilities: 1. Drive IT platform and application governance throughout the system development lifecycle, including design, development, release, change management, and retirement, ensuring regulatory compliance 2. Plan and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities using risk-based GAMP 5 methodologies 3. Lead qualification activities for systems, platforms, cloud environments, and sandboxes, including IQ/OQ/PQ 4. Prepare and review validation documentation such as Validation Plans, Risk Assessments, URS, Functional Specifications, Traceability Matrices, Test Scripts, and Validation Summary Reports 5. Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable pharmaceutical regulatory standards 6. Develop, maintain, and review SOPs, work instructions, system documentation, configuration records, access reviews, and periodic review documents 7. Manage document review and approval workflows using DocuSign or similar e-signature platforms 8. Coordinate with QA, IT, business owners, system owners, security, and data governance teams to obtain necessary reviews and approvals 9. Manage deviations, CAPAs, change controls, and release approvals, ensuring timely closure and audit readiness 10. Ensure GDPR and data privacy compliance, including data classification, data handling, and DPIA documentation 11. Support AI/GenAI governance activities, including model risk assessments, intended-use documentation, human oversight, and monitoring controls 12. Support internal audits, regulatory inspections, and compliance assessments by maintaining appropriate validation evidence and documentation Required Skills: 1. Expertise in IT Quality, Computer System Validation (CSV/CSA), and IT Compliance within pharmaceutical or life sciences environments 2. Strong knowledge of GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11 3. Hands-on experience with IQ/OQ/PQ, system qualification, and validation of cloud-based and SaaS platforms 4. Proficiency in validation documentation, SOPs, URS, FS/DS, test scripts, traceability matrices, and validation reports 5. Experience with SDLC, IT change management, release management, and system lifecycle governance 6. Experience with DocuSign or similar electronic signature and document approval platforms 7. Understanding of GDPR, data privacy, deviations, CAPA, and change control processes 8. Familiarity with AI/GenAI governance and risk management requirements Preferred Skills: 1. Experience with Snowflake, Power BI, Azure, AWS, or other data and analytics platforms in regulated environments 2. Familiarity with ServiceNow, Veeva Vault QualityDocs, or similar quality management systems 3. Knowledge of EU AI Act, NIST AI Risk Management Framework, or enterprise AI governance policies Desired Qualifications: 1. Bachelor’s degree in Computer Science, Information Technology, Pharmaceutical Sciences, or a related field 2. Certification in ASQ CQA/CSQE, GAMP 5, or ISO 27001 Additional Information: Location: India