Validation Engineer

Cardinal Health•Indianapolis, IN

About The Position

What Manufacturing Engineering contributes to Cardinal Health Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes. Manufacturing Engineering is responsible for developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality. Job Summary The Principal Engineer, Manufacturing leads large capital engineering and product design projects. This job oversees the design of products. The job leads project teams to improve product design. The job is also responsible for project budgets. This job leads teams as necessary but is not be a people manager.

Requirements

4-8 years of experience, preferred
Bachelor's degree in related field (engineering), or equivalent work experience, preferred
Strong background in Computerized System Validations (CSV) preferred
Experience working in a regulated industry preferred
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems
Solutions are innovative and consistent with organization objectives
Completes work; independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues

Responsibilities

Maintain inspection readiness and support regulatory audits
Data Integrity & Risk Management Apply ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available)
Perform and document risk assessments to determine validation scope and testing depth
Ensure appropriate controls for audit trails, security, and system access
System Implementation & Change Control Partner with IT and business stakeholders during system implementation and upgrades
Evaluate and document system changes through formal change control processes
Assess impact of patches, upgrades, and configuration changes on validated state

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs