Process Engineer

Katalyst Healthcares and Life Sciences

United States

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.

Requirements:

2-4 years of experience in manufacturing and/or process engineering.
Strong technical writing skills with awareness of intended audience.
bility to effectively communicate with operators, peers, and management in both written and oral formats.
Handson experience with validation protocols.
Experience in medical device and/or regulated manufacturing environment.
Interpersonal Skills:
Persuasive communication and strong interpersonal abilities.
Proficiency with Microsoft Office tools.

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Vacancy posted 2 days ago

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