Validation Engineering Manager

Cardinal Health • Indianapolis, IN

2d

About The Position

What Engineering Management contributes to Cardinal Health Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes. Engineering Management is responsible for strategic oversight and leadership direction within the Engineering function.

Requirements

• 8-12 years of experience, preferred
• Bachelor’s degree in related field (engineering), or equivalent work experience, preferred
• FDA regulated environment experience
• Experience leading a team preferred
• Manages department operations and supervises professional employees, front line supervisors and/or business support staff
• Participates in the development of policies and procedures to achieve specific goals
• Ensures employees operate within guidelines
• Decisions have a short term impact on work processes, outcomes and customers
• Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
• Interactions normally involve resolution of issues related to operations and/or projects
• Gains consensus from various parties involved

Responsibilities

• Lead validation programs across facilities, utilities, equipment, and systems
• Ensure compliance with cGMP, FDA, USP, and other regulatory standards
• Oversee execution of IQ/OQ/PQ, process validation, cleaning validation, and CSV
• Develop and maintain validation documentation (VMPs, protocols, reports, SOPs)
• Manage and mentor validation engineering staff
• Drive risk-based validation and lifecycle management approaches
• Support audits, inspections, and regulatory submissions
• Partner cross-functionally to maintain validated state and resolve deviations

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees