Role Descriptions: Must Have Technical/Functional Skills
· 2-4 years of experience in manufacturing and/or process engineering.
· Strong technical writing skills, with appropriate awareness of intended audience.
· Ability to effectively communicate across multiple audiences, including operators, peers and management,
in both written and oral manners
· Process validation experience.
· Experience in a Medical Device and/or regulated manufacturing work environment.
· Persuasive communication and interpersonal skills.
· Digital literacy, including use of Microsoft Office tools.
Roles & Responsibilities
· Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.)
· Developing and implementing manufacturing processes, preparation of specifications and operator
instructions, process studies, production readiness, investigations, root cause analysis, problem solving
and report or presentation preparation.
· Updating procedures, manufacturing specifications, bills, routes and travelers for product & process
changes in the PLM system.
· Working with OEM equipment manufacturers and distributors to develop user requirements.
· Work on new asset commissioning · Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals. · Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects. · Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
Generic Managerial Skills, If any
· Experience working in a regulated industry, such as Medical Device.
· Experience with machining processes, metal finishing processes, laser processing or production
automation.
· Hands-on experience with machining processes, casting, metal finishing processes, laser processing or
production automation.
· Knowledge of statistical data analysis and associated tools (e.g. Minitab).
· Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Willingness to support global projects, which may include travel
Key Words to search in Resume
validation protocols, IQ, OQ, PQ, manufacturing processes, process studies, new asset commissioning,