22 Sr. Process Engineer Jobs in Bedford, MA
Katalyst Healthcares & Life Sciences is Hiring a Sr. Process Engineer Near Bedford, MA
- 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.
Job Summary
Full Time
$102k-119k (estimate)
05/03/2024
05/16/2024
katalysthls.com
South Plainfield, NJ
<25
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The following is the career advancement route for Sr. Process Engineer positions, which can be used as a reference in future career path planning. As a Sr. Process Engineer, it can be promoted into senior positions as a Chemical Process Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr. Process Engineer. You can explore the career advancement for a Sr. Process Engineer below and select your interested title to get hiring information.
