Lead Computer System Validation- PV W2

Title: Lead Computer System Validation

Location: Lebanon, IN (Onsite 3+ days/week)

Duration: 6-8 months (Contract)

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Responsibilities:

• Lead the delivery and implementation of safety/HSE applications and other site software solutions managing timelines, milestones, and vendor accountability across multiple concurrent projects
• Manage multiple external vendors ensuring deliverables are on-spec, on-time, and aligned with LP1 site requirements and Lilly standards
• Author and manage CSV (Computer System Validation) documentation drafting validation plans, protocols, and reports where needed, and overseeing vendor-authored CSV deliverables through review and approval cycles
• Lead end-to-end CSV efforts for new application deployments from risk assessments and requirements traceability through IQ/OQ/PQ execution and validation closure
• Transition delivered applications into steady-state support owning user onboarding, access management, training, and ongoing system administration
• Manage compliance and incident management processes for supported applications ensuring issues are documented, triaged, and resolved within GxP and site requirements
• Serve as the day-to-day point of contact between site stakeholders (primarily HSE, but also other functions) and vendors/IT partners throughout the software delivery lifecycle
• Document support procedures, system configurations, and runbooks to ensure long-term sustainability and clean handoff at contract end

Skills & Qualifications:

• Experience leading software delivery projects in a regulated pharmaceutical or manufacturing environment comfort with GxP expectations is non-negotiable
• Hands-on CSV experience able to both author validation documentation and critically review vendor-produced deliverables (GSOP-1201 or equivalent familiarity preferred)
• Proven vendor management skills able to hold multiple vendors accountable simultaneously without losing track of dependencies or deadlines
• Strong understanding of application support operations user onboarding, access governance, incident/change management, and compliance workflows
• Familiarity with safety/EHS platforms preferred, but adaptable to whatever toolset is selected
• Excellent organizational skills this role juggles delivery, validation, support, and vendor coordination all at once
• Clear communicator who can translate between technical vendor teams and non-technical site stakeholders
• Self-starter comfortable operating with autonomy in a greenfield environment where processes are still being built