Sr. Principal Quality Engineer

Hobbsnews; Northern (KY); Hybrid; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k

Paid time off

HSA

Disability coverage

Work-Life resources

Job summary

Cardinal Health is seeking a Senior Quality Engineer to develop and execute standardized cleaning validation protocols for the La Vergne site and deploy them across the St. Louis facility, ensuring compliant operations.

The role requires 8–12 years of experience, a related bachelor's degree, and experience with cleaning validations; travel will be high in the first 3–6 months and then 15–25% to support both sites. Cardinal Health offers comprehensive benefits and equal opportunity employment.

Job description

What Quality Engineering contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.

This role would be accountable for developing and executing a standardized cleaning validation protocol for the LaVergne site, followed by deployment of the same protocol at the St. Louis site.

Responsibilities

This role would be accountable for the development and execution of standardized validation protocols for product, process, and cleaning validations within a contract pharmaceutical packaging environment with locations in LaVergne TN and St. Louis MO.

This work is critical to sustaining compliant operations and aligning validation practices across both facilities. The role would also provide ongoing support for PQ/PV execution, Environmental Monitoring, and Temperature Validation.

CHPS is a multi‑site FDA registered custom contract pharmaceutical packaging facility. Specific emphasis for this role is to:

• Develop and execute cleaning validation master plans, protocols, and reports.
• Design cleaning validation studies based on risk assessments and product/equipment characteristics.
• Establish scientifically justified acceptance criteria for residues and contaminants.
• Support lifecycle management of validated cleaning processes

Qualifications

• 8-12 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• Running or executing cleaning validations preferred
• Quality validations experience preferred

Travel

• First 3 - 6 months will include a high level of travel
• After initial project travel will be around 15% - 25% of the time supporting both sites

What is expected of you and others at this level

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
• Participates in the development of policies and procedures to achieve specific goals
• Recommends new practices, processes, metrics, or models
• Works on or may lead complex projects of large scope
• Projects may have significant and long-term impact
• Provides solutions which may set precedent
• Independently determines method for completion of new projects
• Receives guidance on overall project objectives
• Acts as a mentor to less experienced colleagues

• Anticipated salary range: $105,00 - $150,000
  Bonus eligible: Yes
  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
  
• 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.