Kneat Solutions Architect

Req ID: 370290 

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a Kneat Solutions Architect to join our team in Hyderabad, Telangana (IN-TG), India (IN).

Job Title: Kneat Solutions Architect (Global Template & Deployment)

Location: Preferably Hyderabad

Experience: 10+ Years

Industry: Life Sciences / Pharma / Medical Devices

Job Summary

We are seeking an experienced Kneat Solutions Architect to lead the strategic design and technical implementation of the Kneat GX platform. This role will focus on developing global validation templates (CSV, CQV, Equipment, Process Validation) to drive standardization, data integrity, and regulatory compliance across multiple manufacturing sites worldwide.

The ideal candidate will play a critical role in global deployment initiatives, system integrations, and ensuring compliance with GxP regulations (21 CFR Part 11, Annex 11).

Key Responsibilities

1. Global Template Strategy & Design

• Design and develop standardized, reusable digital validation templates within Kneat GX for:
  • Computer System Validation (CSV)
  • Commissioning & Qualification (C&Q)
  • Process Validation
  • Equipment Qualification
• Develop Section Group Templates to streamline requirements, risk management, and template adoption across global sites.
• Align templates with global and local regulatory requirements (21 CFR Part 11, EU Annex 11).
• Map enterprise IT and Quality landscapes to ensure harmonization and scalability.

2. Deployment & Rollout

• Lead end-to-end deployment of Kneat GX across multiple sites (centralized or multi-instance models).
• Drive a “right-first-time” implementation approach ensuring minimal rework.
• Conduct site workshops to adapt global templates to local requirements without compromising standardization.
• Develop and maintain technical specifications and deployment documentation.

3. System Integration & Data Architecture

• Architect integrations between Kneat GX and enterprise systems such as:
  • SAP
  • Jira
  • ERP
  • MES
  • QMS
• Leverage Kneat REST APIs to enable seamless data flow and interoperability.
• Ensure robust data architecture and governance frameworks.

4. Validation & Compliance

• Develop and manage validation plans, protocols, and reports.
• Ensure continuous compliance with GxP, ALCOA++ principles, and data integrity standards.
• Maintain automated audit trails and inspection readiness.

5. Stakeholder Engagement

• Act as a trusted advisor to Quality, Engineering, and IT stakeholders.
• Lead training sessions and workshops on digital validation and template usage.
• Drive change management and user adoption of Kneat GX solutions.

Required Skills & Experience

• Platform Expertise:
  • 8+ years of expert knowledge of Kneat GX or similar GxP e-validation platforms
• Industry Experience:
  • 5+ years in Life Sciences, Pharma, or Medical Devices
  • 5+ years of experience in Validation, QA, or IT domains
• Technical Skills:
  • 5+ years of strong expertise in Computer System Validation (CSV)
  • Knowledge of SDLC, data integrity, and regulatory compliance
  • Experience with system integrations and APIs
• Global Experience:
  • Proven track record in global rollouts or standardization programs
• Communication Skills:
  • Ability to translate technical concepts for business stakeholders
  • Strong presentation and facilitation skills
• Education:
  • Bachelor’s degree in Engineering, Computer Science, or related field

Core Competencies for Success

• Pharma 4.0 Mindset:
  • Align validation strategies with Industry 4.0 and digital transformation
• Audit Readiness:
  • Deep understanding of ALCOA++ principles and electronic records compliance
• Customer-Facing Excellence:
  • Strong stakeholder engagement, workshop facilitation, and consulting skills

Preferred Qualifications (Nice to Have)

• Experience with multi-site global deployments of validation platforms
• Exposure to digital validation transformation initiatives
• Knowledge of regulatory inspections and audit support

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us.

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