Sr. Process Engineer - Katalyst Healthcares & Life Sciences
Bedford, MA 01730
About the Job
Responsibilities :
- Design, develop, and optimize processes for the manufacturing of medical devices, such as injection molding, extrusion, assembly, packaging, sterilization, etc.
- Conduct process characterization, design of experiments (DOE), risk assessment, and statistical analysis to identify and control critical process parameters and sources of variation.
- Write and review process development documents, such as process flow diagrams, process specifications, process failure mode and effects analysis (PFMEA), etc.
- Perform process validation activities, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), in accordance with regulatory requirements and industry standards.
- Develop master validation plans (MVPs) for equipment and processes, ensuring alignment with project objectives and timelines.
- Troubleshoot and resolve process issues during development and manufacturing activities.
- Provide technical guidance and training to junior process development engineers and technicians.
- Maintain current knowledge of process development and validation best practices, regulatory requirements, and industry standards.
- Support product development and transfer projects by working closely with cross-functional teams, such as engineering, quality, manufacturing, and regulatory affairs.
- Demonstrate good manufacturing practices (GMP) related experience of execution and documentation of process development and validation activities, such as MVPs, DOEs, PFMEAs, IQ, OQ, PQ, test method validations (TMVs), etc.
- Evaluate and implement changes to processes based on development and validation results, feedback, or improvement opportunities.
Source : Katalyst Healthcares & Life Sciences