Validation Systems Administrator

Kindeva Drug Delivery

Kneat eValidation administrator supporting Kindeva’s life-saving pharmaceutical and medical products. Configuring validation systems, managing users, and maintaining compliant records across global sites.

Posted 8/15/2026full-timeRemote • Minnesota • 🇺🇸 United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in administering and configuring the Kneat eValidation system, ensuring compliance with GxP and regulatory standards while managing validation lifecycle activities. Proficient in user management, system performance monitoring, and cross-functional collaboration to support quality systems in the pharmaceutical and biotechnology industries.

Highest-signal resume keywords

Kneat eValidation AdministrationValidation Lifecycle ActivitiesGxP ComplianceRegulatory Requirements (21 CFR Part 11, EU Annex 11)User Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ValidationQuality SystemsTemplate CreationWorkspace ConfigurationDocument ManagementSystem ValidationData IntegrityDisaster RecoveryChange ControlCAPA

Soft Skills

Problem-SolvingCommunicationOrganizational SkillsTeam CollaborationIndependence

Tools & Technologies

Kneat eValidation PlatformGMP Computerized Systems

Certifications & Qualifications

Kneat Administrator Certification

Industry Keywords

PharmaceuticalMedical DeviceBiotechnologyCDMORegulated Manufacturing

About the role

Key responsibilities & impact

Administer and configure the Kneat eValidation system across all Kindeva sites
Create, update, and maintain Kneat templates, workspaces, disciplines, document types, and document packs
Manage user accounts, roles, access modifications, and periodic access reviews
Execute and document validation lifecycle activities including IQ/OQ/PQ, protocol execution, discrepancy management, and summary reports
Provide end-user support and troubleshoot Kneat configuration, document routing, and execution issues
Support system release updates through release-note review, validation impact assessments, regression testing, and documentation
Collaborate with Quality, IT, Engineering, Manufacturing, and other cross-functional teams
Assist with user training and onboarding
Support inspection readiness by maintaining complete and accurate records, audit trails, and system documentation
Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable regulations
Support Change Control, CAPA, Deviations, Complaints, and Document Management processes
Participate in governance meetings and harmonization initiatives
Coordinate and execute release testing, including drafting test cases and owning associated change controls
Monitor system performance, logs, and security alerts; troubleshoot issues and implement corrective actions
Maintain configuration and validation documentation
Ensure data integrity, backup, and disaster recovery protocols are in place

Requirements

What you’ll need

8+ years of experience in validation or quality systems in the pharmaceutical, medical device, or biotechnology industry
Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or a related field preferred
Hands-on experience with the Kneat eValidation platform, including template creation, workspace configuration, and user management
Strong background in equipment, computer, AIQ, and process validation
Hands-on experience with GMP computerized systems, 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
Excellent problem-solving, communication, and organizational skills
Ability to work independently and in a global, cross-functional team environment
Kneat administrator certification preferred or willingness to obtain upon hire
Familiarity with GMP regulatory requirements and data integrity principles
CDMO experience is a plus

Benefits

Comp & perks

Remote work
Training and onboarding support