Senior Validation Engineer

Hobbsnews; Indianapolis, Northern (IN, KY); Hybrid; USD 69,000 - 108,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

FlexPay

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health in Indianapolis is seeking a Senior Engineer, Manufacturing to oversee and project manage large validation efforts. You will serve as the technical lead for internal and external engineering teams, managing projects from start to finish without direct people management responsibilities.

The role requires strong expertise in CSV, FDA/EMA/ISO regulatory knowledge, and proven ability to author and review validation protocols (IQ/OQ/PQ).

Qualifications

• Experience in validation within a cGMP pharmaceutical/biotech manufacturing environment preferred.
• Ability to author, execute and review complex validation protocols and reports (IQ/OQ/PQ).
• Strong understanding of regulatory requirements including FDA/EMA/ISO standards.
• Experience with equipment, process, cleaning, utility, facility, and CSV.
• Excellent written and verbal communication and cross-functional collaboration skills.
• Ability to work independently with multiple priorities and minimal supervision.

Responsibilities

• Lead validation planning, scheduling, execution for manufacturing processes and equipment.
• Develop, author, and review validation documentation (URS, FRS, DQ, IQ, OQ, PQ, FAT, SAT, SOPs).
• Ensure activities comply with cGMP and regulatory standards.
• Provide technical support to manufacturing, quality, and engineering teams; investigate deviations.
• Coordinate cross-functional validation projects with vendors and contractors.
• Drive risk-based validation strategies and continuous improvement.
• Support regulatory inspections and audits with validation insights.
• Conduct gap and risk assessments and mitigation plans.

Skills

Validation experience

Regulatory knowledge

Project management

Analytical skills

Communication skills

Statistical analysis

Independent work

Education

Bachelor's degree in Engineering or related scientific discipline

Tools

IQ/OQ/PQ protocols

CSV (computer system validation)

Job description

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.

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

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.

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.