Principal Validation Engineer

Cardinal Health; Legendary Hills (IN); Presencial; USD 82.000 - 129.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Wages access before payday

Descripción de la vacante

Cardinal Health is seeking a Principal Engineer, Manufacturing to lead large validation projects and oversee product and process design validation. You will guide cross-functional teams through complex validation programs, ensuring compliance with cGMP and regulatory expectations.

Ideal candidates will have 6–10 years in validation within pharma/biotech manufacturing, strong data analysis skills, and the ability to mentor junior engineers while delivering on schedule and budget.

Formación

• Bachelor's degree in Engineering or related scientific discipline preferred; master's degree preferred.
• 6–10 years of progressive validation experience in cGMP pharmaceutical/biotech manufacturing.
• Extensive experience with equipment, process, cleaning, utility, facility, media fill, and computer system validation (CSV).
• Regulatory knowledge including FDA, EMA, ISO standards and NRC regulations relevant to nuclear pharma manufacturing.
• Strong analytical, data integrity, and statistical analysis skills; capable of presenting complex info clearly.
• Ability to manage multiple projects and provide mentorship.

Responsabilidades

• Serve as SME for complex validation activities across CSV, equipment, utility, and facilities.
• Lead validation planning, execution, and documentation to meet timelines and regulatory standards.
• Develop and implement risk-based validation strategies and use Quality by Design principles.
• Represent validation in regulatory inspections and audits (FDA, EMA, NRC).
• Collaborate with Manufacturing, Quality Assurance, Engineering, R&D, and Regulatory Affairs to integrate validation throughout product lifecycle.

Conocimientos

Project management

Data analysis

Regulatory knowledge

Communication skills

Problem solving

Critical thinking

Educación

Bachelor's degree in Engineering

Master's degree preferred

Descripción del empleo

What Manufacturing Engineering contributes to Cardinal HealthEngineering 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 SummaryThe 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.ResponsibilitiesServe 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.QualificationsBachelor'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 preferredExtensive 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 preferredAbility to manage weight up to 25 poundsProven track record of leading significant validation projects and contributing to successful regulatory audits preferredStrong 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 levelApplies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projectsMay contribute to the development of policies and proceduresWorks on complex projects of large scopeDevelops technical solutions to a wide range of difficult problemsSolutions are innovative and consistent with organization objectivesCompletes work; independently receives general guidance on new projectsWork reviewed for purpose of meeting objectivesMay act as a mentor to less experienced colleaguesAnticipated salary range: $82,100 - $128,920Bonus eligible: NoBenefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication 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 here