- Design and develop mechanical equipment/components using AutoCAD, Solid Edge, and SolidWorks, ensuring compliance with GMP, cGMP, ISO, and FDA standards.
- Prepare detailed 2D/3D drawings and models as per ASME/IS standards.
- Utilize design software for NPD and process improvement while maintaining regulatory requirements.
- Coordinate with Production, QA, and Maintenance to ensure design feasibility and validation readiness.
- Participate in DQ, IQ, OQ activities for equipment qualification.
- Manage design changes through proper change control and documentation systems.
- Conduct root cause analysis and implement CAPA for design-related issues.
- Maintain accurate documentation and ensure compliance with audit and EHS standards.
Required Skills
- Solid understanding of mechanical design principles.
- Problem-solving and analytical skills.
- Understanding of validation and documentation practices.