Senior Validation Engineer – Manufacturing Projects Lead

cardinalhealth; Indianapolis (IN); On-site; 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 balance programs

Job summary

Cardinal Health in Indianapolis seeks a Senior Engineer, Manufacturing to oversee and project manage large engineering projects and act as the technical lead for internal and external teams. The role manages projects end-to-end from resources to outcomes, without direct people management.

You will lead validation efforts for manufacturing processes, equipment, cleaning, and utilities, ensuring compliance with cGMP and regulatory standards while supporting inspections and audits.

Qualifications

• Bachelor’s degree in Engineering (e.g., Chemical, Mechanical, Electrical, Biomedical) or related scientific discipline (e.g., Chemistry, Biochemistry) preferred.
• 2–4 years of progressive experience in validation within a cGMP pharmaceutical or biotechnology manufacturing environment preferred.
• Ability to manage weight up to 25 pounds.
• Experience with equipment, process, cleaning, utility, facility, and computer system validation (CSV) preferred.
• Strong understanding of regulatory requirements: FDA, EMA, ISO, NRC preferred.
• Proven ability to author, execute, and review complex validation protocols and reports (IQ/OQ/PQ) preferred.
• Exceptional analytical, problem-solving, and critical thinking skills with meticulous attention to detail.
• Strong project management capabilities, including planning, organization, and execution.

Responsibilities

• Lead validation projects including qualification, validation, and requalification activities for manufacturing processes, equipment, utilities, products, cleaning, and sterilization.
• Develop, author, and review validation documentation (URS, FRS, DQ, IQ, OQ, PQ, FAT, SAT, protocols, reports, SOPs).
• Ensure validation activities and documentation comply with cGMP and regulatory agencies (FDA, EMA, ISO, NRC).
• Provide technical expertise and support to manufacturing, quality, and engineering teams; assist in deviations and root cause investigations.
• Manage and coordinate validation projects with cross-functional teams, vendors, and contractors to meet timelines.
• Develop and implement policies, programs, and quality standards to meet regulatory requirements.
• Support regulatory inspections and audits with validation strategies and documentation.
• Conduct gap and risk assessments and develop mitigation strategies.
• Drive continuous improvement in the validation program with risk-based approaches.

Skills

Analytical skills

Problem solving

Critical thinking

Project management

Communication

Education

Bachelor's degree in Engineering or related science

Job description

Cardinal Health in Indianapolis seeks a Senior Engineer, Manufacturing to oversee and project manage large engineering projects and act as the technical lead for internal and external teams. The role manages projects end-to-end from resources to outcomes, without direct people management.

You will lead validation efforts for manufacturing processes, equipment, cleaning, and utilities, ensuring compliance with cGMP and regulatory standards while supporting inspections and audits.