Principal Validation Engineer

Cardinal Health; Indianapolis, Northern (IN, KY); Hybrid; USD 82,000 - 129,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day (myFlex

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health seeks a Principal Validation Engineer to lead large capital engineering and product design projects within a nuclear pharmaceutical manufacturing context. You will oversee validation planning, execution and documentation, ensuring alignment with cGMP standards and regulatory expectations across FDA/EMA/NRC inspections.

As SME, you will mentor junior engineers, drive risk-based validation using QbD, and collaborate across Manufacturing, Quality and Regulatory Affairs to maintain

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Biomedical) or related field.
• Master's degree preferred for advanced roles.

Responsibilities

• Serve as SME for complex validation activities (process, equipment, cleaning, utility, facility, CSV).
• Lead planning, execution and documentation of validation projects to meet timelines and regulatory requirements.
• Design, author, execute, and review DQ/IQ/OQ/PQ protocols and reports with statistical justification.
• Lead investigations for deviations and non-conformances with robust CAPA actions.
• Develop risk-based validation strategies integrating Quality by Design principles.
• Represent validation during regulatory inspections (FDA/EMA/NRC) and audits.
• Collaborate with Manufacturing, Quality, Engineering, R&D and Regulatory Affairs.
• Provide mentorship to less experienced Validation Engineers and guide best practices.

Skills

Validation expertise

Regulatory compliance

Statistical analysis

Project management

Data integrity

Deviations and CAPA

Root cause analysis

Quality systems

Cross-functional collaboration

Mentorship/leadership

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

Quality software systems

Job description

Principal Validation Engineer page is loaded## Principal Validation Engineerlocations: IN-Indianapolis-Theranostics Commercialtime type: Full timeposted on: Posted Yesterdayjob requisition id: 20188614***What Manufacturing Engineering contributes to Cardinal Health***Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes.Manufacturing Engineering is responsible for developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality.***Job Summary***The Principal Engineer, Manufacturing leads large capital engineering and product design projects. This job oversees the design of products. The job leads project teams to improve product design. The job is also responsible for project budgets. This job leads teams as necessary but is not be a people manager.***Responsibilities**** Serve as a subject matter expert (SME) for complex validation activities, including process, equipment, cleaning, utility, facility, and computer system validation (CSV), providing advanced technical guidance for nuclear pharmaceutical manufacturing sites.* Lead the planning, execution, and documentation of complex validation projects, ensuring adherence to project timelines, quality standards, and regulatory requirements.* Contribute to the development, implementation, and continuous improvement of validation master plans, policies, and procedures, ensuring alignment with current industry best practices and evolving regulatory requirements (e.g., cGMP, FDA, EMA, ISO, and NRC).* Design, author, execute, and review complex validation protocols (DQ, IQ, OQ, PQ) and reports, ensuring scientific soundness, statistical justification, and regulatory compliance.* Act as a lead investigator for complex deviations, out-of-specification results, and non-conformances related to validated systems, performing thorough root cause analysis and implementing effective corrective and preventive actions (CAPAs).* Contribute to the development and implementation of risk-based validation strategies, including the application of Quality by Design (QbD) principles, to optimize validation efforts and ensure robust process control.* Represent the validation department during internal and external regulatory inspections and audits (e.g., FDA, EMA, NRC), providing detailed explanations and defending validation strategies and documentation.* Collaborate extensively with cross-functional teams, including Manufacturing, Quality Assurance, Engineering, R&D, and Regulatory Affairs, to integrate validation requirements throughout the product lifecycle.* Provide technical guidance and mentorship to less experienced Validation Engineers, fostering their professional development and ensuring consistency in validation practices.* Evaluate new technologies, equipment, and processes for their impact on the validated state and develop appropriate validation approaches.* Stay abreast of emerging industry trends, regulatory changes, and advanced validation methodologies, proactively integrating relevant updates into Cardinal Health's validation program.***Qualifications**** Bachelor's degree in Engineering (e.g., Chemical, Mechanical, Electrical, Biomedical) or a related scientific discipline (e.g., Chemistry, Biochemistry) preferred. A master's degree is preferred.* 6 - 10 years of progressive experience in validation within a cGMP pharmaceutical or biotechnology manufacturing environment preferred* Extensive experience with equipment, process, cleaning, utility, facility, media fill, and computer system validation (CSV) preferred.* Demonstrated expertise in regulatory requirements, including FDA (21 CFR Parts 210, 211, 820), EMA, ISO standards, and specifically NRC regulations relevant to nuclear pharmaceutical manufacturing preferred* Ability to manage weight up to 25 pounds* Proven track record of leading significant validation projects and contributing to successful regulatory audits preferred* Strong analytical, problem-solving, and critical thinking abilities, with a focus on data integrity and statistical analysis.* Excellent written and verbal communication skills, capable of presenting complex technical information clearly and concisely to diverse audiences.* Strong project management skills, including the ability to manage multiple projects simultaneously and drive them to successful completion.* Deep understanding of quality systems (e.g., deviations, CAPAs, change control) and their integration with validation activities preferred.* Ability to influence and collaborate effectively with stakeholders across various departments.* Ability to provide technical guidance and mentorship to junior colleagues.***What is expected of you and others at this level**** Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects* May contribute to the development of policies and procedures* Works on complex projects of large scope* Develops technical solutions to a wide range of difficult problems* Solutions are innovative and consistent with organization objectives* Completes work; independently receives general guidance on new projects* Work reviewed for purpose of meeting objectives* May act as a mentor to less experienced colleagues**Anticipated salary range:** $82,100 - $128,920**Bonus eligible:**No**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.* Medical, dental and vision coverage* Paid time off plan* Health savings account (HSA)* 401k savings plan* Access to wages before pay day with myFlexPay* Flexible spending accounts (FSAs)* Short- and long-term disability coverage* Work-Life resources* Paid parental leave* Healthy lifestyle programs**Application window anticipated to close:** 12/2/2026 \\*if interested in opportunity, please submit application as soon as possible.The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.*To read and review this privacy notice click*Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges - now, and in the future.