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Process Engineer
Job
Katalyst Healthcares and Lifesciences
Raynham, MA (In Person)
Full-Time
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Job Description
Roles & Responsibilities Write and execute validation protocols and reports (IQ, OQ, PQ). Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities. Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations. Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems. Work with equipment manufacturers and distributors to develop user requirements. Partner with Operations, OpEx, Planning, Engineering, and Quality teams to align validation strategy, author documents, coordinate execution, and manage approvals. Ensure adherence to FDA regulations, regulatory requirements, company policies, and operating procedures. Identify opportunities for process improvement and implement best practices. Maintain positive and cooperative communication with employees, customers, contractors, and vendors. Background in medical device or other regulated industries. Experience with machining, metal finishing, laser processing, or production automation. Practical exposure to machining, casting, finishing, laser processing, or automation. Knowledge of statistical data analysis tools (e.g., Minitab). Basic understanding of Geometric Dimensioning and Tolerancing. Willingness to support global projects, including travel.