Principal Validation Engineer | CSV & GMP Expert

Cardinal Health; Indianapolis, Northern (IN, KY); Hybrid; USD 82,000 - 129,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day (myFlex

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health seeks a Principal Validation Engineer to lead large capital engineering and product design projects within a nuclear pharmaceutical manufacturing context. You will oversee validation planning, execution and documentation, ensuring alignment with cGMP standards and regulatory expectations across FDA/EMA/NRC inspections.

As SME, you will mentor junior engineers, drive risk-based validation using QbD, and collaborate across Manufacturing, Quality and Regulatory Affairs to maintain

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Biomedical) or related field.
• Master's degree preferred for advanced roles.

Responsibilities

• Serve as SME for complex validation activities (process, equipment, cleaning, utility, facility, CSV).
• Lead planning, execution and documentation of validation projects to meet timelines and regulatory requirements.
• Design, author, execute, and review DQ/IQ/OQ/PQ protocols and reports with statistical justification.
• Lead investigations for deviations and non-conformances with robust CAPA actions.
• Develop risk-based validation strategies integrating Quality by Design principles.
• Represent validation during regulatory inspections (FDA/EMA/NRC) and audits.
• Collaborate with Manufacturing, Quality, Engineering, R&D and Regulatory Affairs.
• Provide mentorship to less experienced Validation Engineers and guide best practices.

Skills

Validation expertise

Regulatory compliance

Statistical analysis

Project management

Data integrity

Deviations and CAPA

Root cause analysis

Quality systems

Cross-functional collaboration

Mentorship/leadership

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

Quality software systems

Job description

Cardinal Health seeks a Principal Validation Engineer to lead large capital engineering and product design projects within a nuclear pharmaceutical manufacturing context. You will oversee validation planning, execution and documentation, ensuring alignment with cGMP standards and regulatory expectations across FDA/EMA/NRC inspections.

As SME, you will mentor junior engineers, drive risk-based validation using QbD, and collaborate across Manufacturing, Quality and Regulatory Affairs to maintain