Validation Systems Administrator

Role Responsibilities

• Kneat System Administration: 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.
• Aid in training and onboarding users in Kneat functionality and best practices for compliant use.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field preferred.
• 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.
• Kneat admin certification preferred (or willingness to obtain upon hire).
• Familiarity with GMP regulatory requirements and the importance of data integrity in a validated system.