8 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
Contractor
$112k-131k (estimate)
06/08/2024
07/01/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Sr. Process Engineer include Analysis, Process Development, Installation, Packaging, Alignment, etc. Having related job skills and expertise will give you an advantage when applying to be a Sr. Process Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Sr. Process Engineer. Select any job title you are interested in and start to search job requirements.
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.
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