Description :

Job Title : Kneat Developer / Kneat Validation Specialist

Employment Type : Permanent

Location : PAN India

Experience Level : Mid to Senior Level

Job Summary :

We are looking for an experienced Kneat Developer with strong expertise in Kneat configuration, validation process mapping, and compliance documentation. The role involves configuring and supporting Kneat as a standalone validation system, enabling digital validation workflows, and training site-level power users. The ideal candidate will have a solid understanding of CSV (Computer System Validation) within regulated environments and hands-on experience with Kneat implementation and administration.

Key Responsibilities (KRAs) :

Kneat Configuration & Administration :

- Configure and maintain Kneat validation workflows, templates, and lifecycle stages.

- Customize Kneat to support GxP-compliant validation processes across multiple disciplines.

- Manage user roles, permissions, and system access within Kneat.

- Support Kneat as a standalone validation system, ensuring stability and compliance.

Validation & Compliance :

- Author, review, and manage validation documentation by discipline (IQ, OQ, PQ, RTM, SOPs, protocols, reports).

- Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and data integrity requirements.

- Support audits and inspections by providing Kneat system documentation and validation evidence.

- Maintain traceability and version control of validation artifacts within Kneat.

Process Mapping & Digital Transformation :

- Perform process mapping of existing paper-based or legacy validation processes and convert them into digital Kneat workflows.

- Collaborate with QA, Validation, IT, and Business stakeholders to optimize validation lifecycle processes.

- Identify opportunities to standardize and streamline validation activities using Kneat.

Training & Enablement :

- Act as a Certified Kneat Power User Trainer.

- Conduct training sessions for site power users, validation teams, and QA stakeholders.

- Develop training materials, SOPs, and user guides for Kneat usage.

- Provide ongoing support and guidance to site teams post-training.

System Support & Continuous Improvement :

- Troubleshoot Kneat configuration and user issues.

- Coordinate with Kneat vendor support for issue resolution and upgrades.

- Participate in system enhancements, upgrades, and regression testing.

- Drive continuous improvement initiatives for digital validation maturity.

Technical Skills & Requirements :

Must-Have Skills :

- Strong hands-on experience with Kneat configuration and administration.

- Proven expertise in validation process mapping and digital validation workflows.

- Experience authoring validation documentation by discipline.

- Certified or qualified to perform Kneat Power User Training.

- Good understanding of GxP compliance and CSV principles.

- Experience working with Kneat as a standalone validation system.

Good-to-Have / Add-On Skills :

- Working knowledge of SQL and/or Python (for reporting, data analysis, or automation).

- Database knowledge (data structures, queries, validation evidence extraction).

- Exposure to system integrations or reporting tools is an advantage.

Qualifications :

- Bachelors degree in Engineering, Computer Science, Life Sciences, or related discipline.

- Relevant certifications in CSV, Validation, or Quality Systems are a plus.

- Kneat certification or formal Kneat implementation experience preferred.

Soft Skills :

- Strong communication and documentation skills.

- Ability to train, mentor, and support diverse site teams.

- Strong analytical and problem-solving mindset.

- Ability to work independently across multiple sites and stakeholders.

- Detail-oriented with a strong focus on quality and compliance.