Senior Veeva Vault System Specialist

🔥 1 minute ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

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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 Veeva Vault Documents, Training, and Quality Management System modules • Maintain user accounts, roles, groups, permissions, and access requests • Assist with configuration of document types, metadata, workflows, lifecycle states, templates, vocabularies, roles, and permissions • Provide first-line user support, triage issues, document incidents, and escalate complex items • Support controlled document routing, workflow troubleshooting, version control, issuance, archiving, and metadata quality checks • Create and update work instructions, quick reference guides, training materials, job aids, and support communications • Assist with reports, dashboards, metrics, and data extracts • Participate in change control, testing, approvals, and controlled implementation • Translate cross-functional requirements into system solutions • Support Change Control, CAPA, Deviations, Complaints, and Document Management processes • Establish and maintain global templates for SOPs, forms, documentation management, and quality system modules • Lead or participate in governance forums, quality councils, and harmonization initiatives • Support Veeva Vault releases, regression testing, defect documentation, and deployment readiness • Support validation and compliance deliverables, including test cases, evidence capture, traceability, and system documentation • Collaborate with Quality, IT, Validation, Training, Document Control, Engineering, Automation, HR, and business stakeholders • Ensure data integrity, backup, and disaster recovery protocols • Monitor system logs and security alerts and implement corrective actions

🎯 Requirements

• Must be able to work 6 PM–2 AM EST • Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field preferred, not required • Bachelor’s degree plus 5 years or Master’s degree plus 3 years of experience in the pharmaceutical or biotechnology industry • Minimum 2 years of experience in Quality Systems, Document Control, IT systems support, regulated operations, validation support, or life sciences business systems • Basic understanding of GxP, data integrity, document control, training, change control, or QMS processes preferred • Strong attention to detail and ability to follow controlled procedures in a regulated environment • Ability to document issues clearly, capture objective evidence, and communicate status to stakeholders • Proficiency with Microsoft Office, especially Excel, Word, PowerPoint, Teams, and Outlook • Ability to work independently and in a global, cross-functional team environment • Certified system administrator with Veeva or equivalent