Validation Systems Administrator

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Oversee the daily administration and configuration of the Kneat eValidation system across all Kindeva locations.

• Develop, update, and maintain templates, workspaces, disciplines, and document types within Kneat to facilitate site validation processes.

• Ensure the system is properly configured, provide user support, and maintain records in compliance with GxP standards and internal SOPs.

• Conduct user management tasks including account creation, assigning roles, modifying access, and performing periodic access reviews for all Kindeva site users.

• Implement and document validation lifecycle activities (IQ/OQ/PQ, protocol execution, discrepancy management, and summary reports) utilizing Kneat workflows under the direction of the validation team.

• Offer daily end-user support and troubleshoot issues related to Kneat configuration, document routing, and execution inquiries.

• Assist with Kneat system release updates by reviewing release notes, supporting validation impact assessments, conducting regression testing, and documenting findings.

• Collaborate with Quality, IT, Engineering, and Manufacturing teams to ensure compliant system utilization and adherence to SOPs and validation requirements.

• Aid in training and onboarding users on Kneat functionalities and best practices for compliant usage.

• Coordinate, draft, and execute test cases for Kneat releases and updates, including managing the associated change controls.

• Monitor system performance and resolve issues while maintaining documentation for system configuration and validation activities.

⛳️ Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or a related field is preferred.

• A minimum of 2 years of experience in validation and quality systems within the pharmaceutical, medical device, or biotechnology sectors.

• Practical experience with the Kneat eValidation platform, including template creation, workspace configuration, and user management.

• Strong problem-solving, communication, and organizational abilities.

• Capability to work independently and collaboratively in a global, cross-functional team setting.

• Practical experience with GMP computerized systems, focusing on system validation and regulatory compliance.

• Familiarity with GMP computerized systems, 21 CFR Part 11, and EU Annex 11 requirements in a regulated manufacturing context.

• Kneat admin certification is preferred (or a willingness to obtain it upon hiring).

• Understanding of GMP regulatory requirements and the significance of data integrity in a validated system.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options