Note: The job is a remote job and is open to candidates in USA. Kindeva Drug Delivery is a company dedicated to making products that save lives and improve patient health globally. The Validation Systems Administrator is responsible for the administration and configuration of the Kneat eValidation system to support validation activities across all Kindeva sites, ensuring compliance with regulatory standards and providing user support.
Responsibilities
- Create, update, and modify Kneat templates, document types, and document packs for all Kindeva sites, ensuring they reflect current SOPs and validation requirements
- Set up and maintain workspaces and disciplines in Kneat for all Kindeva sites, configuring site-specific settings and ensuring correct workspace structure for each location
- Perform user management activities including account creation, role assignments, access modifications, and periodic access reviews for all Kindeva site users
- Execute and document validation lifecycle activities (IQ/OQ/PQ, protocol execution, discrepancy management, and summary reports) using Kneat workflows under guidance from the validation team
- Provide day-to-day end-user support and troubleshooting for Kneat configuration issues, document routing problems, and execution queries across all Kindeva sites
- Support Kneat system release updates by reviewing release notes, assisting with validation impact assessments, executing regression testing, and documenting results
- Collaborate with Quality, IT, Engineering, and Manufacturing teams to ensure compliant system use and alignment with SOPs and validation requirements
- Assist in training and onboarding users in Kneat functionality and best practices for compliant use
- Support inspection readiness activities by ensuring Kneat records, audit trails, and system documentation are complete and accurate
- Ensure system compliance with GxP, 21 CFR Part 11, EU Annex 11, and other applicable regulations
- Collaborate with cross-functional teams to understand requirements and translate them into system solutions
- Support quality processes such as Change Control, CAPA, Deviations, Complaints, and Document Management
- Ensure alignment with GMP and other regulatory requirements
- Establish and maintain Kneat procedures, and templates
- Participate in cross-functional governance meetings and harmonization initiatives as directed
- Stay informed on Kneat system updates, new features, and relevant regulatory guidance under the direction of the Kneat Administrator
- Assist in the delivery of Kneat user training and onboarding for new users across Kindeva sites
- Coordinate, draft test cases and test Kneat releases and updates including owning the associated change controls
- Monitor system performance and troubleshoot issues
- Maintain documentation for system configuration and validation activities
- Ensure data integrity, backup, and disaster recovery protocols are in place
- Monitor system logs and security alerts; implement corrective actions as needed
Skills
- 2+ years of experience in validation, quality systems in the pharmaceutical, medical device or biotechnology industry
- Hands-on experience with the Kneat eValidation platform, including template creation, workspace configuration, and user management
- Excellent problem-solving, communication, and organizational skills
- Ability to work independently and in a global, cross-functional team environment
- Hands on experience with GMP computerized systems, including system validation and regulatory compliance
- Working knowledge of GMP computerized systems, 21 CFR Part 11, and EU Annex 11 requirements in a regulated manufacturing environment
- Familiarity with GMP regulatory requirements and the importance of data integrity in a validated system
- Bachelor's or Master's degree in Engineering, Life Sciences, Pharmacy, or related field preferred
- Kneat admin certification preferred (or willingness to obtain upon hire)
Company Overview
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