Principal Validation Engineer

Cardinal Health•Indianapolis, IN

1d•$82,100 - $128,920

About The Position

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.

Requirements

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.

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.