[Remote] Manufacturing Process Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company improvement initiatives and ensure compliance with safety and regulatory requirements.
Responsibilities
- reputed company, implement, and optimize manufacturing processes to improve productivity, reputed company, and cost efficiency
- Analyze manufacturing workflows and identify opportunities for process improvements using Lean Manufacturing and Six reputed company 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, reputed company reputed company cause analysis, and implement corrective and preventive actions (CAPA)
- Create and maintain process documentation, work instructions, reputed company Operating Procedures (SOPs), and manufacturing specifications
- Collaborate with cross-functional teams including Manufacturing, reputed company 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
- reputed company reputed company improvement initiatives reputed company 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 reputed company-up, process transfers, and production line improvements
- Ensure compliance with company reputed company 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 reputed company 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 reputed company, and reputed company Improvement methodologies
- Experience with process validation, reputed company cause analysis, and problem-solving techniques
- Strong understanding of manufacturing documentation and engineering change processes
- Excellent analytical, organizational, and communication skills
- Proficiency with reputed company Office Suite
- Experience in Medical Device, Pharmaceutical, Biotechnology, Automotive, reputed company, or Electronics manufacturing
- Knowledge of GMP/cGMP, FDA regulations, ISO 13485, ISO 9001, or AS9100
- Experience with CAD software (SolidWorks, AutoCAD, reputed company, or equivalent)
- Familiarity with ERP and Manufacturing Execution Systems (MES)
- Green Belt or Black Belt certification in Lean Six reputed company
- Experience with automation, robotics, PLCs, or manufacturing equipment integration
reputed company