Process Engineer – Validation & Maintenance

Job Summary

The Process Engineer will support manufacturing operations at the East Hartford site by executing validation activities, maintaining critical production equipment, and developing compliant procedures. This role ensures that processes remain in a validated state, equipment operates reliably, and documentation meets regulatory and quality system requirements.

• Validation
  • Develop, execute, and document equipment and process validation activities (IQ/OQ/PQ).
  • Maintain validation documentation in accordance with FDA, ISO, and Cardinal Health Quality System requirements.
  • Conduct risk assessments, gap analyses, and change control evaluations.
  • Support revalidation efforts following equipment modifications, process improvements, or deviations.
  • Partner with cross functional teams to ensure validated processes remain compliant and robust.
• Maintenance & Process Support
  • Provide engineering support for daily manufacturing operations, troubleshooting equipment and process issues.
  • Collaborate with Maintenance to develop preventive and predictive maintenance strategies. Perform preventive maintenance as needed.
  • Analyze equipment performance data to identify trends and drive reliability improvements.
  • Support equipment upgrades, replacements, and new installations, ensuring proper qualification and documentation.
• Procedure & Documentation Development
  • Write, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and technical documentation.
  • Ensure documentation aligns with Good Manufacturing Practices (GMP) and internal quality standards.
  • Train operators and technicians on new or updated procedures.
  • Support internal and external audits by ensuring documentation accuracy and readiness.

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or Similar) preferred.
• Lean or Six Sigma certification or training preferred.
• Experience in a regulated manufacturing environment preferred (medical device, pharmaceutical, biotech, or similar).
• Knowledge of validation principles, GMP, and quality system regulations.
• Experience with equipment qualification (IQ/OQ/PQ), preferred.
• Familiarity with root cause analysis tools (5 Whys, Fishbone, FMEA) preferred.
• Experience with CMMS systems and reliability engineering concepts preferred.
• Strong analytical, problem‑solving, and technical writing skills.
• Ability to work cross‑functionally in a fast‑paced environment.

$62,500 - $89,200

No

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before payday with myFlex Pay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
  
  Healthy lifestyle programs

4/6/26
* 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.

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.