Validation Systems Administrator

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

📋 Description

• Oversee and configure the Kneat eValidation system across all Kindeva locations.

• Develop, update, and sustain Kneat templates, workspaces, disciplines, document types, and document packs.

• Manage user accounts, roles, access changes, and conduct periodic access evaluations.

• Execute and document validation lifecycle tasks including IQ/OQ/PQ, protocol execution, discrepancy management, and summary reporting.

• Provide support to end-users and resolve issues related to Kneat configuration, document routing, and execution.

• Facilitate system release updates by reviewing release notes, assessing validation impacts, performing regression testing, and documenting findings.

• Collaborate with Quality, IT, Engineering, Manufacturing, and various cross-functional teams.

• Assist in user training and onboarding processes.

• Support inspection readiness by ensuring comprehensive and accurate records, audit trails, and system documentation are maintained.

• Ensure adherence to GxP, 21 CFR Part 11, EU Annex 11, and other relevant regulations.

• Aid in Change Control, CAPA, Deviations, Complaints, and Document Management processes.

• Participate in governance meetings and harmonization initiatives.

• Coordinate and perform release testing, which includes drafting test cases and overseeing related change controls.

• Monitor system performance, logs, and security alerts; troubleshoot issues and implement corrective measures.

• Maintain configuration and validation documentation.

• Ensure data integrity, backup, and disaster recovery protocols are established.

⛳️ Requirements

• A minimum of 8 years of experience in validation or quality systems within the pharmaceutical, medical device, or biotechnology sectors.

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

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

• Strong expertise in equipment, computer, AIQ, and process validation.

• Hands-on experience with GMP computerized systems, system validation, and regulatory compliance.

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

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

• Capability to work autonomously as well as in a global, cross-functional team environment.

• Preferably holds Kneat administrator certification or is willing to obtain it upon hiring.

• Understanding of GMP regulatory requirements and data integrity principles.

• Experience in CDMO is advantageous.

🏝️ Benefits

• Opportunity for remote work.

• Support for training and onboarding.