Regulated Manufacturing Process Engineer & Validation

Katalyst CRO; Alpharetta (GA); On-site; USD 85,000 - 115,000; Full time

Job summary

Katalyst CRO seeks a Manufacturing Engineer to sustain and improve manufacturing processes and semi-automated equipment in a regulated environment. You will own equipment performance, troubleshoot issues, and drive continuous improvements, while ensuring FDA/ISO compliance and robust documentation.

The role requires a mechanical or electrical engineering background, 2+ years in a regulated setting, and experience with validation (IQ/OQ/PQ) and lean six sigma practices.

Qualifications

• Bachelor's degree in mechanical, electrical, or related engineering discipline.
• 2+ years of engineering experience in a regulated manufacturing environment.
• Hands-on experience with mechanical systems, equipment, and tooling.
• Electrical troubleshooting and controls fundamentals.
• Experience supporting or owning semi-automated manufacturing equipment.
• Lean/Six Sigma experience.
• Exposure to manufacturing systems (MES, SAP).

Responsibilities

• Maintain and continuously improve established manufacturing processes, tooling, and semi-automated systems.
• Own equipment performance, reliability, and long-term sustainability.
• Troubleshoot mechanical and electrical issues using structured root cause methodologies.
• Drive equipment and process improvements, including error-proofing and uptime optimization.
• Execute validation activities (IQ/OQ/PQ) and maintain technical documentation.
• Ensure compliance with FDA, ISO, and internal quality system requirements.
• Support CAPA, nonconformance investigations, and audit readiness.
• Provide real-time production support and drive continuous improvement initiatives.
• Train and guide technicians and operators on processes and equipment.

Skills

Root cause analysis

Electrical troubleshooting

Mechanical systems

Cross-functional collaboration

Lean / Six Sigma

Problem solving

Education

Bachelor's degree in mechanical or electrical engineering

Tools

MES

SAP

Job description

Katalyst CRO seeks a Manufacturing Engineer to sustain and improve manufacturing processes and semi-automated equipment in a regulated environment. You will own equipment performance, troubleshoot issues, and drive continuous improvements, while ensuring FDA/ISO compliance and robust documentation.

The role requires a mechanical or electrical engineering background, 2+ years in a regulated setting, and experience with validation (IQ/OQ/PQ) and lean six sigma practices.