Senior Validation Engineer - Pharma Systems Lead

Cardinal Health; Indianapolis, Northern (IN, KY); Hybrid; USD 69,000 - 108,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

HSA

Job summary

Cardinal Health is seeking a Senior Engineer, Manufacturing to lead validation projects for pharmaceutical manufacturing processes, equipment, and utilities. You will author validation plans and reports, ensure cGMP compliance, and coordinate cross-functional teams to meet timelines.

You will support audits, drive risk-based validation strategies, and provide technical excellence across manufacturing, quality, and engineering groups.

Qualifications

• Bachelor's degree in Engineering or related science required.
• 2–4 years of validation experience in cGMP pharma/biotech settings preferred.
• Strong knowledge of FDA/EMA/ISO/NRC regulatory expectations and CSV practices.

Responsibilities

• Lead validation projects from planning through execution and closing.
• Develop, author, and review URS/FRS/DQ/IQ/OQ/PQ and SOPs.
• Ensure compliance with cGMP and regulatory standards across sites.
• Support manufacturing, quality, and engineering teams to troubleshoot deviations.
• Coordinate cross functional teams, vendors and contractors to meet timelines.
• Develop and implement risk-based validation strategies and improvements.
• Support regulatory inspections with expert validation input.

Skills

Validation protocols

Regulatory knowledge

Project management

Analytical thinking

Independent work

Education

Bachelor's degree in Engineering

Job description

Cardinal Health is seeking a Senior Engineer, Manufacturing to lead validation projects for pharmaceutical manufacturing processes, equipment, and utilities. You will author validation plans and reports, ensure cGMP compliance, and coordinate cross-functional teams to meet timelines.

You will support audits, drive risk-based validation strategies, and provide technical excellence across manufacturing, quality, and engineering groups.