Kneat Implementation Lead

Role Overview:

The Kneat Implementation Lead is responsible for planning, executing, and overseeing the implementation and continuous improvement of the Kneat electronic validation documentation platform across pharmaceutical CQV (Commissioning, Qualification & Validation) operations. This position plays a critical role in enhancing digital compliance, data integrity, and workflow efficiency for pharmaceutical manufacturing and validation processes.

Key Responsibilities:

• Lead the end-to-end implementation and rollout of Kneat in pharmaceutical CQV and quality operations.
• Manage project scope, timelines, and resources for Kneat deployment—coordinating with IT, Engineering, Quality, and CQV stakeholders.
• Customize and configure validation workflows, templates, and protocols within Kneat to align with company and regulatory requirements.
• Develop and deliver training for end users, including CQV, Engineering, Validation, and Quality teams, fostering adoption and proficiency.
• Author and maintain documentation for system configuration, user instructions, and digital SOPs.
• Facilitate migration of legacy validation records to Kneat; ensure data integration and integrity throughout the transition.
• Monitor system performance, user feedback, and compliance to identify opportunities for continuous improvement.
• Support internal and external audits with validated, inspection-ready digital documentation from Kneat.
• Act as primary liaison with Kneat and relevant vendors for support, upgrades, and troubleshooting.
• Stay current with pharmaceutical industry regulatory expectations (FDA, EMA, MHRA, ISPE) regarding digital validation and data integrity.
• Champion best practices in digital validation documentation and electronic records management.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related technical discipline.
• Minimum 10 years’ experience in pharmaceutical manufacturing, quality, or CQV, with proven track record in digital validation/documentation systems.
• Hands-on experience implementing and managing Kneat or comparable electronic validation platforms in pharma.
• Deep understanding of cGMP, FDA, EMA, and ISPE guidelines regarding validation and electronic documentation.