Role Descriptions: Must Have TechnicalFunctional Skills
2-4 years of experience in manufacturing andor 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 andor 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.
Skills: EIS : Medical Device & Regulations EIS : Manufacturing Engineering Support
Experience Required: 4-6
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