Process Engineer – Validation & Maintenance

Cardinal Health • East Hartford, CT

8d

About The Position

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.

Requirements

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or Similar) preferred.
• Knowledge of validation principles, GMP, and quality system regulations.
• Strong analytical, problem‑solving, and technical writing skills.
• Ability to work cross‑functionally in a fast‑paced environment.

Nice To Haves

• Lean or Six Sigma certification or training preferred.
• Experience in a regulated manufacturing environment preferred (medical device, pharmaceutical, biotech, or similar).
• 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.

Responsibilities

• 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.
• 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.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level