Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes. The role involves collaborating with various teams to drive continuous improvement initiatives and ensure compliance with safety and regulatory requirements.
Responsibilities
- Develop, implement, and optimize manufacturing processes to improve productivity, quality, and cost efficiency
- Analyze manufacturing workflows and identify opportunities for process improvements using Lean Manufacturing and Six Sigma methodologies
- Support new product introduction (NPI), process development, and technology transfer activities
- Design, validate, and document manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), where applicable
- Investigate production issues, perform root cause analysis, and implement corrective and preventive actions (CAPA)
- Create and maintain process documentation, work instructions, Standard Operating Procedures (SOPs), and manufacturing specifications
- Collaborate with cross-functional teams including Manufacturing, Quality Assurance, R&D, Maintenance, Supply Chain, and Regulatory Affairs
- Support equipment selection, installation, commissioning, and validation activities
- Monitor process performance using statistical tools such as Statistical Process Control (SPC) and process capability analysis
- Lead continuous improvement initiatives focused on cycle time reduction, waste elimination, yield improvement, and cost savings
- Participate in Failure Mode and Effects Analysis (FMEA), risk assessments, and process validation activities
- Support manufacturing scale-up, process transfers, and production line improvements
- Ensure compliance with company quality systems, safety procedures, and applicable regulatory requirements including GMP/cGMP, FDA, and ISO standards
- Train manufacturing personnel on new processes, equipment, and standardized work procedures
- Prepare technical reports, engineering documentation, and project status updates
Skills
- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline
- 2–5 years of manufacturing or process engineering experience
- Experience supporting manufacturing operations in regulated or high-volume production environments
- Knowledge of Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies
- Experience with process validation, root cause analysis, and problem-solving techniques
- Strong understanding of manufacturing documentation and engineering change processes
- Excellent analytical, organizational, and communication skills
- Proficiency with Microsoft Office Suite
- Experience in Medical Device, Pharmaceutical, Biotechnology, Automotive, Aerospace, or Electronics manufacturing
- Knowledge of GMP/cGMP, FDA regulations, ISO 13485, ISO 9001, or AS9100
- Experience with CAD software (SolidWorks, AutoCAD, Creo, or equivalent)
- Familiarity with ERP and Manufacturing Execution Systems (MES)
- Green Belt or Black Belt certification in Lean Six Sigma
- Experience with automation, robotics, PLCs, or manufacturing equipment integration
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