Ecocareers ยท 2 days ago
Validation Engineer
Jersey City, NJ
Full-time
Onsite
Entry, Mid Level
2+ years expConfidential company is seeking a Validation Engineer to ensure compliance with FDA regulations and support validation strategies. The role involves writing validation protocols, developing manufacturing processes, and collaborating with multi-functional teams to ensure product and process changes are effectively implemented.
Staffing & Recruiting
Responsibilities
Writing and execution of validation protocols and reports (ie. 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
Qualification
Required
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
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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase