Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is seeking a Manufacturing Process Engineer to enhance their manufacturing processes within a regulated environment. The role involves improving equipment performance, troubleshooting issues, and ensuring compliance with quality standards.
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
- 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
Benefits
- Work model: remote, onsite
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