Principal Validation Engineer

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 Healths validation program.

Qualifications

• Bachelors degree in Engineering (e.g. Chemical Mechanical Electrical Biomedical) or a related scientific discipline (e.g. Chemistry Biochemistry) preferred. A masters 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) 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: $82100 - $128920

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 candidates 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.

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