Validation Systems Administrator

🔥 1 minute ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

⌨️ Systems Administrator

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Kindeva Drug Delivery

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🏥 Healthcare

💊 Pharmaceuticals

🏭 Manufacturing

💰 $42M Grant on 2023-09

Healthcare • Pharmaceuticals • Manufacturing

Kindeva Drug Delivery is a purpose‑fueled drug delivery CDMO (contract development and manufacturing organization) that provides development, analytical, manufacturing, fill-finish, regulatory and post-commercialization services focused on specialist drug delivery formats including sterile injectables, pulmonary (inhalation), nasal and dermal delivery. The company operates multiple facilities across the US and UK (Bridgeton, MO; Brentwood, MO; Maryland Heights, MO; Loughborough, UK; Clitheroe, UK; Woodbury, MN; Northridge, CA; Union City, CA; Lexington, KY; Germantown, MD) and emphasizes capabilities in aseptic/sterile manufacturing, advanced fill-finish operations, and drug-delivery platform technologies (autoinjectors, microneedle patches, pMDIs, nasal MDIs, dose counters, dual-chamber injectors). Kindeva positions itself as an innovation-driven partner helping pharmaceutical companies fast-track development and commercial supply, with investments in green propellants and Annex 1-compliant sterile facilities.

📋 Description

• Responsible for the day-to-day administration and configuration of the Kneat eValidation system across all Kindeva sites. • Create, update, and maintain templates, workspaces, disciplines, and document types within Kneat to support site validation activities. • Ensure the system is configured correctly, users are supported, and records are maintained in compliance with GxP requirements and internal SOPs. • 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. • 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. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options