Cardinal Health

Principal Validation Engineer

Cardinal Health • $82K — $128K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or related scientific discipline; master's preferred.
  • 6-10 years of validation experience in cGMP pharmaceutical or biotechnology environments.
  • Extensive knowledge of validation processes including equipment, cleaning, and computer systems.
  • Expertise in regulatory requirements (FDA, EMA, ISO, NRC) for nuclear pharmaceuticals.
  • Strong analytical and problem-solving skills with a focus on data integrity.
  • Excellent communication skills for diverse audiences.
  • Proven project management abilities with a track record of leading validation projects.

Responsibilities

  • Serve as a subject matter expert for complex validation activities in nuclear pharmaceutical manufacturing.
  • Lead planning, execution, and documentation of validation projects, ensuring compliance with timelines and standards.
  • Develop and improve validation master plans and policies aligned with industry best practices.
  • Design and execute validation protocols and reports, ensuring scientific and regulatory compliance.
  • Investigate deviations and non-conformances, implementing corrective actions as needed.
  • Develop risk-based validation strategies using Quality by Design principles.
  • Represent the validation department during regulatory inspections and audits.

Benefits

  • Medical, dental, and vision coverage.
  • Paid time off plan.
  • Health savings account (HSA).
  • 401k savings plan.
  • Access to wages before payday with myFlexPay.
  • Flexible spending accounts (FSAs).
  • Short- and long-term disability coverage.
  • Work-Life resources.
  • Paid parental leave.
  • Healthy lifestyle programs.
Full Job Description
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.

About Cardinal Health

Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough stents, catheters and guidewires for interventional medicine, minimally invasive computer-based imaging, and electrophysiology.

Cardinal Health Careers

Joining Cardinal Health means becoming part of a team committed to pushing the boundaries of healthcare innovation and leadership. As a global leader in healthcare services and products, we offer unparalleled job opportunities designed to empower your career growth. Work You’ll Do At Cardinal Health, we are dedicated to creating an environment where professionals can thrive through diverse training and robust career development. We believe in fostering a culture that values diversity and drives innovation. Lead in a Dynamic Field Take a leading role in the healthcare industry with Cardinal Health. Our team is at the forefront of developing solutions that improve patient care and reduce costs. With positions ranging from logistics and operations to advanced analytics and pharmaceutical development, your work will directly impact lives around the world. Join Our Inclusive Team Be part of a culture that celebrates diversity and is committed to creating an inclusive environment for all employees. At Cardinal Health, we understand that unique perspectives lead to innovative ideas and better decision-making. Innovate with Us Our commitment to innovation is fundamental. Cardinal Health is a place where you can work with cutting-edge technology and collaborate with industry experts to deliver solutions that make healthcare safer and more effective. Grow Your Career Cardinal Health supports your professional growth with comprehensive benefits, continuous learning opportunities, and a clear path to advancement. From leadership programs to internships, we provide the tools to build your skills and advance your career. Explore Job Opportunities Whether you’re looking for an internship, a full-time position, or a leadership role, Cardinal Health offers a range of employment options to help you meet your career goals. Our hiring process is designed to match your skills and interests with the right opportunities within our company. Stay Connected Join Our Team Search for open positions that align with your skills and interests. We are always looking for passionate, curious, and solution-driven team players. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here. Networking and Professional Development Enhance your career with our networking events, professional development sessions, and comprehensive benefits designed to boost your career journey. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Cardinal Health. Join Cardinal Health today and be part of a team that’s dedicated to improving the future of healthcare. Explore our careers page to find out how you can contribute to our mission and advance your professional journey.
Learn more about Cardinal Health
Size
47,300 employees
Market Cap
$20.8 billion
Industry
Healthcare
Net Income
$1.3 billion
Founded
1971
5 Year Trend
+6.9%
Revenue
$156.4 billion
NASDAQ
CAH
* Ladders Estimates

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