Validation Engineering Manager

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
• Bachelors 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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