Senior Validation Engineer, Pharmaceutical CSV

Cardinal Health, Inc.; Indianapolis (IN); On-site; USD 82,000 - 129,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

MyFlexPay access

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. seeks a Principal Engineer, Manufacturing to lead large capital validation projects and oversee product design validation. You will guide cross‑functional teams and ensure adherence to regulatory standards while managing budgets and timelines.

The role emphasizes development of validation strategies, CAPAs, and collaboration with QA, Engineering, and Regulatory Affairs to optimize validated states across the product lifecycle.

Qualifications

• Bachelor's degree in Engineering or related scientific discipline; master's preferred.
• 6–10 years validation experience in cGMP pharma/biotech manufacturing.
• Experience with equipment, process, cleaning, utility, and CSV validation.
• Strong regulatory knowledge (FDA, EMA, ISO, NRC) related to nuclear pharma.

Responsibilities

• Lead complex validation projects and review protocols (DQ/IQ/OQ/PQ).
• Act as SME for complex validation activities across sites.
• Develop risk-based validation strategies and CAPAs.
• Prepare documentation for regulatory inspections and audits.
• Mentor junior Validation Engineers and collaborate with cross-functional teams.

Skills

Analytical thinking

Regulatory awareness

Cross-functional collaboration

Project management

Mentorship

Technical communication

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

CSV validation knowledge

Quality by Design (QbD)

Job description

Cardinal Health, Inc. seeks a Principal Engineer, Manufacturing to lead large capital validation projects and oversee product design validation. You will guide cross‑functional teams and ensure adherence to regulatory standards while managing budgets and timelines.

The role emphasizes development of validation strategies, CAPAs, and collaboration with QA, Engineering, and Regulatory Affairs to optimize validated states across the product lifecycle.