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We are looking for a Medical writer and Regulatory Affairs associate.
Primary function of the position:
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

We are looking for a talented Quality Engineer, who will be responsible for the implementation of effective quality controls, inspection methods, and evaluation of the reliability of manufacturing processes, products, and production equipment. Joining the team means being part of an elite group of innovators with a passion for creating future-defining and groundbreaking technologies that shape our everyday lives.

Responsibilities:

* Implement effective quality controls, teach production staff how to use them, and supervise outcomes.
* Implementing inspection methods and evaluating the reliability of manufacturing processes, products, and production equipment.
* Preparing the company for quality audits of customers and international standardization organizations.
* Led CAPA and Root cause analysis, and responsible for task management.
* MRB - Management and tracking.
* Responsible for the company's calibration system.
* Monitors suppliers performance and reports key process indicator to upper management.
* Working in accordance with deadlines for delivery of products.
* Leading certifications of products for new standards & regulations.

* Research and development of novel dielectric materials for use in additive manufacturing microfabrication.
* Hands-on resin formulation of novel resins for 3D DLP printing based with acrylates, epoxies, etc.
* Formulation of composite resins with various fillers and additives (application of dispersion techniques).
* Characterization of formulation and functionality (e.g. dispersion quality, curing characteristics, rheology, surface tension)
* Characterization of polymeric materials (e.g. mechanical and thermal properties)
* Close collaboration with process engineering
* Management of health and safety regulations in the laboratory

Group:
Fabrica

We are looking for an Instrument and Controls Engineer to join our Israeli team based in Kiryat Gat (office/site based 5 Days per Week) who is excited about working on advanced facilities projects that enable the heart of our clients business. Join us and you will have the chance to work on projects at some of the worlds most state of the art industrial and commercial facilities.
Youll be accountable for developing Piping & Instrument Diagrams (P&ID) following ANSI/ISA S5.1 symbology, and panel design including panel layout and wiring diagrams, Youll also manage demanding project schedules, prepare accurate reports, and demonstrate communication skills.
were partnering across the globe to create the best project outcomes by maximizing the design, digital technology, and support capabilities of our Global Integrated Delivery (GID) teammates.
By joining us, youll commit to supporting and engaging with these teams, as we work to build a company like no other.
Bring your curiosity, talent for multi-tasking and collaboration, and extreme organizational skills and well help you grow, pursue and fulfill what drives you so we can make big impacts on the world, together.