Senior Validation Engineer – Pharma/CSV Expert

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

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Health savings account

FSAs

Job summary

Cardinal Health, Inc. is seeking a Principal Engineer, Manufacturing to lead large capital engineering and product design projects and oversee validated systems across the product lifecycle.

The role requires extensive validation experience in a cGMP environment, strong regulatory knowledge, and the ability to mentor others while collaborating with cross-functional teams. The position includes a broad benefits package and annual salary range expectations.

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Biomedical) or related field; master's preferred.
• 6–10 years of progressive validation experience in cGMP pharmaceutical/biotech manufacturing preferred.
• Extensive experience with CSV, equipment, process, cleaning, utility, and facility validation.
• Regulatory knowledge including FDA, EMA, ISO, NRC preferred.
• Ability to manage up to 25 pounds.
• Proven track record leading validation projects and audits.

Responsibilities

• Serve as SME for complex validation activities across validation life cycle.
• Lead validation project planning, execution, and documentation to meet timelines and standards.
• Develop and implement validation master plans, policies, and procedures.
• Lead investigations for deviations and CAPA activities.
• Contribute to risk-based validation strategies and QbD applications.
• Represent validation in regulatory inspections and audits.
• Collaborate with cross-functional teams to integrate validation across product life cycle.
• Provide mentorship to junior Validation Engineers.

Skills

Validation expertise

Regulatory knowledge

Project management

Analytical thinking

Communication skills

Education

Bachelor's in Engineering

Master's degree preferred

Job description

Cardinal Health, Inc. is seeking a Principal Engineer, Manufacturing to lead large capital engineering and product design projects and oversee validated systems across the product lifecycle.

The role requires extensive validation experience in a cGMP environment, strong regulatory knowledge, and the ability to mentor others while collaborating with cross-functional teams. The position includes a broad benefits package and annual salary range expectations.