Validation Engineering Manager

Location: IN-Indianapolis-Theranostics Commercial

Time Type: Full time

Job Description

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.

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

Qualifications

• 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

What is expected of you and others at this level

• 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

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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