Senior Validation Engineer: Manufacturing Projects Lead

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. in Indianapolis is seeking a Senior Engineer, Manufacturing to oversee and project manage large engineering initiatives.

This role serves as the technical lead for internal and external teams, driving validation programs from start to finish while not acting as a people manager. You will coordinate validation activities across facilities, ensure compliance with cGMP and FDA/EMA standards, and partner with manufacturing, quality and engineering to drive continuous

Qualifications

• Bachelor's degree in Engineering (e.g., Chemical, Mechanical, Electrical, Biomedical) or related science preferred.
• 2–4 years of progressive validation experience in a cGMP pharmaceutical/biotech manufacturing environment.
• Experience with validation protocols (IQ/OQ/PQ) and reports is preferred.
• Ability to lift up to 25 pounds and perform routine validation tasks.

Responsibilities

• Lead validation projects, including qualification, validation, and requalification activities.
• Develop, author, and review URS/FRS/DQ/IQ/OQ/PQ, FAT/SAT, tests and SOPs.
• Ensure validation activities comply with cGMP and regulatory requirements (FDA/EMA/ISO/NRC).
• Provide technical support to manufacturing, quality, and engineering teams and investigate deviations.
• Coordinate with cross-functional teams, vendors and contractors to meet timelines.
• Drive risk-based validation strategies and continuous improvement within the program.

Skills

Project management

Validation experience

Cross-functional teamwork

Attention to detail

Education

Bachelor's degree in Engineering or related science

Job description

Cardinal Health, Inc. in Indianapolis is seeking a Senior Engineer, Manufacturing to oversee and project manage large engineering initiatives.

This role serves as the technical lead for internal and external teams, driving validation programs from start to finish while not acting as a people manager. You will coordinate validation activities across facilities, ensure compliance with cGMP and FDA/EMA standards, and partner with manufacturing, quality and engineering to drive continuous