Cardinal Health

Senior Validation Engineer

Cardinal Health • $68K — $107K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or related scientific discipline preferred.
  • 2-4 years of progressive experience in cGMP pharmaceutical or biotechnology validation preferred.
  • Demonstrated experience with manufacturing validation and computer system validation (CSV) preferred.
  • Strong understanding of FDA, EMA, ISO, and NRC regulatory requirements relevant to pharmaceutical manufacturing preferred.
  • Proven ability to author and review complex validation protocols and reports (IQ/OQ/PQ) preferred.
  • Exceptional analytical and problem-solving skills with attention to detail preferred.
  • Excellent communication skills for collaboration with diverse teams.

Responsibilities

  • Lead planning and execution of validation projects for manufacturing processes and equipment.
  • Develop and review detailed validation documentation and reports.
  • Ensure compliance of all validation activities with regulatory standards and company policies.
  • Provide technical expertise to troubleshoot and resolve manufacturing and quality deviations.
  • Manage validation projects with cross-functional teams and external partners.
  • Implement quality standards to meet industry and regulatory requirements.
  • Support regulatory inspections by providing expert validation insights.

Benefits

  • 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
Full Job Description
Job Summary

The Senior Engineer, Manufacturing oversees and project manages large engineering projects. This job serves as the technical lead for both internal and external engineering teams. The senior engineer is responsible for the management of projects from start to end from both a resource management and outcome perspective. This job leads teams as necessary but is not be a people manager.

Responsibilities
  • Lead the planning, scheduling, execution, and leadership of various validation projects, including qualification, validation, and requalification activities for manufacturing processes, equipment, critical utility systems, products, cleaning, and sterilization processes.
  • Develop, author, and review comprehensive validation documentation, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), validation plans, protocols, test scripts, summary reports, and Standard Operating Procedures (SOPs).
  • Ensure all validation activities and documentation comply with cGMP, pharmaceutical regulatory agencies (e.g., FDA, EMA, ISO, NRC), product license requirements, and Cardinal Health policies.
  • Provide technical expertise and support to manufacturing, quality, and engineering teams, assisting in troubleshooting, investigating, and resolving deviations, and performing thorough root cause investigations.
  • Manage and coordinate validation projects, collaborating effectively with cross-functional teams, vendors, and contractors to meet project timelines and objectives.
  • Develop and implement policies, programs, and quality standards to meet current industry, corporate Quality, and external regulatory requirements regarding validation.
  • Support internal and external regulatory inspections and audits by providing expert insights and defending validation strategies and documentation.
  • Conduct gap and risk assessments to identify potential compliance issues and develop mitigation strategies.
  • Drive continuous improvement initiatives within the validation program, establishing risk-based validation strategies to enhance efficiency and regulatory compliance.


Qualifications
  • Bachelor's degree in Engineering (e.g., Chemical, Mechanical, Electrical, Biomedical) or a related scientific discipline (e.g., Chemistry, Biochemistry) preferred.
  • Minimum of 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
  • Demonstrated experience with equipment, process, cleaning, utility, facility, and computer system validation (CSV) preferred
  • Strong understanding of regulatory requirements, including FDA (21 CFR Parts 210, 211, 820), EMA, ISO standards, and specifically NRC regulations relevant to nuclear pharmaceutical manufacturing 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 a meticulous attention to detail preferred
  • Strong project management capabilities, including planning, organization, and execution preferred
  • Excellent written and verbal communication skills for effective collaboration with diverse teams and stakeholders.
  • Ability to work independently, manage multiple priorities, and make sound decisions with minimal supervision.
  • Proficiency in statistical analysis for validation data is a plus.


What is expected of you and others at this level
  • Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possible solutions to a variety of technical problems and takes action to resolve
  • Applies judgment within defined parameters
  • Receives general guidance and may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy


Anticipated salary range: $68,500 - $107,580

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: 10/28/2026 *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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