KH
Manufacturing Process Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
2 months ago
- Lean Manufacturing
- Six Sigma
- CAPA
- SPC
- FMEA
- GMP
- CAD
- SolidWorks
- AutoCAD
- Creo
- ERP
- Green Belt
- Black Belt
- Lean Six Sigma
- PLC
2 months ago
We are seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes to improve efficiency, quality, and productivity. The ideal candidate will work closely with Manufacturing, Quality, Operations, R&D, and Supply Chain teams to drive continuous improvement initiatives, resolve production issues, and ensure compliance with safety and regulatory requirements in a fast-paced manufacturing environment.
Roles & 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.
- 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.
Manufacturing Process Engineer · Katalyst Healthcares & Life Sciences