Senior Validation Engineer — Manufacturing Lead

Cardinal Health, Inc.; Legendary Hills (IN); On-site; USD 69,000 - 108,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

PTO

HSA

401k

Advance pay option

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health, Inc. is seeking a Senior Engineer, Manufacturing to lead validation projects for pharmaceutical manufacturing processes and equipment.

You will serve as the technical lead on internal and external teams, managing projects from start to finish without direct people management responsibility. You will author and review validation plans, URS/FSRs and IQ/OQ/PQ, while ensuring adherence to regulatory standards and corporate policies.

Qualifications

• Bachelor's degree in Engineering or related science preferred.
• 2-4 years of validation experience in cGMP pharma/biotech manufacturing preferred.
• Ability to lift up to 25 pounds.
• Experience with equipment, process, cleaning, utility, facility and CSV validation.
• Strong regulatory understanding (FDA/EMA/ISO; NRC for nuclear).
• Proven ability to author, execute and review validation protocols and reports.
• Analytical, problem-solving and meticulous attention to detail.
• Strong project management and organizational skills.
• Excellent written and verbal communication; work with cross-functional teams.
• Ability to work independently with multiple priorities.
• Statistical analysis knowledge is a plus.

Responsibilities

• Lead validation projects planning, scheduling, execution and leadership.
• Develop, author and review validation docs (URS, FRS, IQ/OQ/PQ, FAT/SAT, SOPs).
• Ensure validation activities comply with cGMP and regulatory requirements.
• Provide technical support to manufacturing, quality and engineering teams.
• Coordinate validation projects with cross-functional teams, vendors and contractors.
• Develop and implement policies and standards for validation.
• Support regulatory inspections and audits with validation insights.
• Conduct gap and risk assessments; drive mitigation strategies.
• Drive continuous improvement in the validation program.

Job description

Cardinal Health, Inc. is seeking a Senior Engineer, Manufacturing to lead validation projects for pharmaceutical manufacturing processes and equipment.

You will serve as the technical lead on internal and external teams, managing projects from start to finish without direct people management responsibility. You will author and review validation plans, URS/FSRs and IQ/OQ/PQ, while ensuring adherence to regulatory standards and corporate policies.