Senior Validation Engineer

What Manufacturing Engineering contributes to Cardinal Health

Engineering 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.

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.

• 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.

• 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.

• Applies working knowledge in the application of concepts,…