Role: Validation Engineer

Scope of Services:

The projects will include creating required system documentation for Elanco computer systems and/or infrastructure platforms. The specific deliverables and their respective due dates are controlled at the project level, so no specific deliverables or timelines are included in this scope. The typical services and deliverables included are:

Overarching expectations:

• Understand the Elanco compliance landscape by adhering to the Elanco Global Quality Standards (EGQS), Elanco Functional Procedures (EFPs), Elanco Common SOPs (ECSOPs), and applicable departmental processes
• Assess compliance of all deliverables in scope of project
• Maintain document sharing process
• Escalate any concerns to the Quality representative
• Partner with SMEs (business and IT) as needed to ensure the success of the project
• Meet all deadlines and escalate concerns of potentially missed deadlines early
• Communicate effectively with team members and other groups to ensure consistent and complete documentation from project
• Self-manage the tasks assigned to them according to required timelines
• Acquire and implement Elanco documentation standards and practices
• Understand and document linkages, relationships and dependencies between various project phases
• Establish as the documentation SME for technical and process documentation

Validation or System Documentation:

• Participate in the Supplier Evaluation Risk Process
• Participate in System Risk Assessment discussions and document results
• Drive the development of the Validation (or Qualification) Strategy document with input from appropriate SMEs and Quality team
• Assist in writing, with the appropriate IT SMEs, applicable supporting system documentation
• Performs the planning, writing and editing of documentation required for tracking and compliance with the applicable departmental policies and guidelines
• Makes recommendations on system documentation
• Functions as the point of contact for project/projects documentation
• Helps organize existing and new documentation
• Acquire and apply knowledge of the business and of overarching standards that apply to the project scope
• Collaborate with Subject Matter Experts (SME’s) to identify documentation points to ensure a functional, viable relationship between requirements and technical specifications match

Status Reporting:

• Reports status of validation and qualification deliverables

General Requirements:

• Work will be performed remote for the near term
• Work may require travel to the Elanco Greenfield, Indiana facility
• Work may require travel to Hook, UK to support the team

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