Kneat Validation Systems Administrator

Kindeva; Woodbury (MN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical benefits

401k benefits

Paid time off

Job summary

Kindeva Drug Delivery is seeking a Kneat eValidation Administrator to manage templates, workspaces, and user access across multiple sites. This role ensures validation records meet GxP and regulatory requirements while collaborating with Quality, IT, Engineering, and Manufacturing teams.

The ideal candidate has extensive Kneat experience, strong problem-solving, and the ability to work in a global, cross-functional environment.

Qualifications

• 8+ years in validation/quality systems within pharma, medical device, or biotech industries.
• Hands-on Kneat experience: templates, workspace config, and user management.
• Strong knowledge of GMP, 21 CFR Part 11, and EU Annex 11 compliance.

Responsibilities

• Configure Kneat templates, document types, and packs reflecting SOPs across all Kindeva sites.
• Set up workspaces and disciplines for site-specific settings and correct structure.
• Manage user accounts, roles, and access reviews for Kneat users.

Skills

Kneat eValidation

Validation & QA

GxP compliance

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s or Master’s degree in Engineering or Life Sciences

Tools

Kneat

Job description

11200 Hudson Rd, Woodbury, MN 55129, USA

Job Description

Posted Friday, August 14, 2026 at 5:00 AM

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

This exciting new position at Kindeva! This role is responsible for the day-to-day administration and configuration of the Kneat eValidation system across all Kindeva sites. The Kneat Validation System administrator creates, updates, and maintains templates, workspaces, disciplines, and document types within Kneat to support site validation activities. Working under the direction of the leader, this role ensures the system is configured correctly, users are supported, and records are maintained in compliance with GxP requirements and internal SOPs.

Key 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.
• CDMO experience is a plus, with exposure to supporting multiple clients, projects, or validation strategies within Kneat‑supported environments.
• 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.

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.
• 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.

Qualifications

• 8+ years of experience in validation, quality systems in the pharmaceutical, medical device or biotechnology industry
• Bachelor’s or Master’s degree preffered in Engineering, Life Sciences, Pharmacy, or related field .
• Hands-on experience with the Kneat eValidation platform, including template creation, workspace configuration, and user management.
• Strong background in all disciplines of validation (i.e. equipment, computer, AIQ, process)
• 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

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

11200 Hudson Rd, Woodbury, MN 55129, USA