Validation Systems Administrator

🔥 1 minute ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

⌨️ 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

• 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

• 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

• Remote work • Training and onboarding support