Manufacturing Process Engineer

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

Job DescriptionResponsible for sustaining and improving manufacturing processes and semi-automated equipment to support safe, compliant, and efficient production within a regulated environment.

Job DescriptionResponsible for sustaining and improving manufacturing processes and semi-automated equipment to support safe, compliant, and efficient production within a regulated environment.

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.

Requirements:

• 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.
• Strong problem-solving and root cause analysis capability.
• Medical device manufacturing experience.
• Experience with validation processes (IQ/OQ/PQ) and quality systems.
• Lean / Six Sigma experience.
• Exposure to manufacturing systems (e.g., MES, SAP).
• Basic familiarity with automated equipment and controls.

Key Competencies:

• Technical problem solving track record of resolving technical problems using critical thinking skills and proven methodologies (6-step problem-solving, DMAIC, etc.).
• Cross-functional collaboration can work collaboratively with other functions and encourages transparency, feedback, and respectful disagreements/challenges all for the greater good of improving the production unit, site, and ultimately the company.
• Ownership and accountability drive individually owned tasks to completion within the timeframe aligned with team or management, fully understands and owns the role of an ME, owns up to mistakes and failures and is transparent about it but also strives to resolve and rectify mistakes.
• Continuous improvement mindset willingness to always be learning and improving oneself, their team, and their production unit.
• Ability to learn quickly not afraid to fail fast and learn from mistakes; willingness to learn new things quickly and correctly apply learnings.