Senior Validation Engineer - Lead Manufacturing Projects

Hobbsnews; 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

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

FlexPay

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health in Indianapolis is seeking a Senior Engineer, Manufacturing to oversee and project manage large validation efforts. You will serve as the technical lead for internal and external engineering teams, managing projects from start to finish without direct people management responsibilities.

The role requires strong expertise in CSV, FDA/EMA/ISO regulatory knowledge, and proven ability to author and review validation protocols (IQ/OQ/PQ).

Qualifications

• Experience in validation within a cGMP pharmaceutical/biotech manufacturing environment preferred.
• Ability to author, execute and review complex validation protocols and reports (IQ/OQ/PQ).
• Strong understanding of regulatory requirements including FDA/EMA/ISO standards.
• Experience with equipment, process, cleaning, utility, facility, and CSV.
• Excellent written and verbal communication and cross-functional collaboration skills.
• Ability to work independently with multiple priorities and minimal supervision.

Responsibilities

• Lead validation planning, scheduling, execution for manufacturing processes and equipment.
• Develop, author, and review validation documentation (URS, FRS, DQ, IQ, OQ, PQ, FAT, SAT, SOPs).
• Ensure activities comply with cGMP and regulatory standards.
• Provide technical support to manufacturing, quality, and engineering teams; investigate deviations.
• Coordinate cross-functional validation projects with vendors and contractors.
• Drive risk-based validation strategies and continuous improvement.
• Support regulatory inspections and audits with validation insights.
• Conduct gap and risk assessments and mitigation plans.

Skills

Validation experience

Regulatory knowledge

Project management

Analytical skills

Communication skills

Statistical analysis

Independent work

Education

Bachelor's degree in Engineering or related scientific discipline

Tools

IQ/OQ/PQ protocols

CSV (computer system validation)

Job description

Cardinal Health in Indianapolis is seeking a Senior Engineer, Manufacturing to oversee and project manage large validation efforts. You will serve as the technical lead for internal and external engineering teams, managing projects from start to finish without direct people management responsibilities.

The role requires strong expertise in CSV, FDA/EMA/ISO regulatory knowledge, and proven ability to author and review validation protocols (IQ/OQ/PQ).