Principal Validation Engineer

Cardinal Health, Inc.; Indianapolis (IN); On-site; USD 79,000 - 120,000; Full time

Job summary

A leading healthcare company is seeking a Principal Validation Engineer to support its Nuclear and Precision Health Solutions. This role involves developing validation plans for cGMP systems and ensuring compliance across manufacturing facilities. Applicants should have a degree in Engineering or Physical Science and relevant experience in validation roles, with a focus on regulatory standards and efficient process improvement.

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

Qualifications

• 5+ years of relevant validation experience preferred.
• Knowledgeable in FDA or ICH qualification.
• Experience in Biotech, Pharmaceutical or Medical Device operations preferred.

Responsibilities

• Assure compliance of validated systems for clinical and commercial stage GMP manufacturing.
• Author, execute, review, and summarize commissioning and qualification protocols for GMP systems.
• Provide general technical advice on new and existing equipment to maintain validation status.

Skills

Technical writing

Communication

Attention to detail

Education

Bachelor’s degree in Engineering or a Physical Science

Tools

Document Management Systems

Job description

Schedule: Monday through Friday 8:00 AM – 5:00PM.

Anticipated salary range:$79,700 - $119,490

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:07/31/2025 *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.

The Principal Validation Engineer is responsible for supporting the validation program for Cardinal Health’s Nuclear and Precision Health Solutions (NPHS) organization. Reporting to the Director of Validations, this position will develop and review plans and protocols for new and existing cGMP systems across our network of manufacturing facilities, including production equipment, laboratory instrumentation, and systems. The individual will also perform facility-level protocol executions at our Indianapolis, IN location, while providing guidance to local project teams on a range of validation and qualification initiatives to ensure existing systems remain within a validated state.

Qualifications:

• Bachelor’s degree in Engineering or a Physical Science.
• 5+ years of relevant validation experience preferred.
• Knowledgeable in FDA or ICH qualification.
• Experience in Biotech, Pharmaceutical or Medical Device operations including protocol development and field execution, preferred.
• Experience with GMP manufacture of radiopharmaceuticals, preferred.
• Excellent technical writing, communication and interpersonal skills.
• Strong attention to detail.
• Knowledgeable in the use of controlled Document Management Systems.

Responsibilities:

• Assure compliance of validated systems for both clinical and commercial stage GMP manufacturing facilities.
• Author, execute, review, and summarize commissioning and qualification protocols for GMP systems including manufacturing equipment, laboratory instrumentation, utilities, spreadsheets, and computer systems.
• Develop and/or review master level plans for validation projects, as well as qualifications and validations of equipment, facilities, and utilities, including cleaning, sterilization, and manufacturing processes.
• Author user requirement specifications for new equipment.
• Provide general technical advice on new equipment, and modifications to existing equipment, to ensure validation/qualification status is maintained in a state of control.
• Provide both on-site and remote validation support to manufacturing facilities and provide technical assistance to site personnel.
• Support Corrective and Preventative Action (CAPA) and Non-conformance processes to ensure thorough investigation and timely resolution of quality issues
• Work cross functionally within the organization to ensure a cohesive approach to validation is maintained.
• Collaborate with cross-functional teams to determine validation requirements, troubleshoot issues, and improve processes.
• Provide guidance and support to Validation SME or serve as Validation SME during audits and inspections.
• Stay abreast of industry trends in validation and expectations of regulatory agencies to improve the validation program.
• Identify and implement improvements in the validation program including procedures, protocols, reports, and systems.

What is expected of you and others at this level:

• Applies comprehensive knowledge and thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
• Works on complex projects of a large scope and develops technical solutions to a wide range of issues. Solutions are innovative and consistent with organizational objectives.
• Maintains data integrity through strict adherence to standardized procedures and relevant compliance requirements. Clearly documents all work activities in a timely manner
• Works in a controlled environment requiring special attention to environmental, health, and safety regulations.
• Works effectively and cooperatively with others, and to establish and maintain good working relationships.
• Completes work independently and receives guidance on new projects.
• Contributes to the development of policies and procedures.
• Ability to effectively manage multiple projects simultaneously, including prioritizing tasks.
• Occasional travel required (<10%)

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

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/Affirmative Action 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.