Lead Validation Engineer - Nuclear Pharma CSV Expert

Cardinal Health; Indiana (PA); On-site; USD 81,000 - 129,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Health savings account (HSA)

Disability coverage

Job summary

Cardinal Health is seeking a Principal Engineer, Validation to lead complex validation projects across equipment, processes, and computer systems in a cGMP pharmaceutical setting. You will guide teams, develop validation strategies, and ensure regulatory compliance.

The role requires deep knowledge of FDA/EMA/ISO standards, along with strong analytical and mentoring capabilities to drive quality and efficiency in validation activities.

Qualifications

• Bachelor's degree in Engineering or related discipline; master's preferred.
• 6–10 years of progressive validation experience in a cGMP pharmaceutical/biotech manufacturing environment.
• Extensive experience with equipment, process, cleaning, utility, facility, media fill, and CSV validation.
• Regulatory knowledge including FDA (21 CFR Parts 210, 211, 820), EMA, ISO, and NRC where relevant.
• Ability to manage physical tasks up to 25 pounds.
• Proven track record leading validation projects and contributing to regulatory audits.
• Strong analytical, problem-solving, and communication skills.
• Ability to influence across departments and mentor junior colleagues.

Responsibilities

• Serve as SME for complex validation activities and provide advanced technical guidance.
• Lead planning, execution, and documentation of validation projects to meet timelines and standards.
• Contribute to validation master plans, policies, and procedures.
• Design, author, execute, and review complex validation protocols and reports.
• Act as lead investigator for deviations and non-conformances with CAPAs.
• Develop and implement risk-based validation strategies and QbD principles.
• Represent validation during regulatory inspections and audits.
• Collaborate with cross-functional teams to integrate validation throughout product lifecycle.
• Provide mentorship to junior Validation Engineers.
• Evaluate new technologies and validation approaches to maintain robust controls.

Skills

Analytical thinking

Project management

Regulatory knowledge

Quality systems

Mentorship

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

CSV validation

Job description

Cardinal Health is seeking a Principal Engineer, Validation to lead complex validation projects across equipment, processes, and computer systems in a cGMP pharmaceutical setting. You will guide teams, develop validation strategies, and ensure regulatory compliance.

The role requires deep knowledge of FDA/EMA/ISO standards, along with strong analytical and mentoring capabilities to drive quality and efficiency in validation activities.