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    Sr. Process Engineer - Bedford, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Bedford, United States

    1 week ago

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    Description
    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.
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