Process validation & NPI engineer

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    "description": "<p><span style=\"font-weight: bold\"><span style=\"text-decoration: underline\">Position: Process </span></span><span style=\"font-weight: bold\"><span style=\"text-decoration: underline\">Validation &amp; NPI Engineer</span></span></p>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">LTS</span> is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.</p>\n<p>LTS´ commercial offering encompasses more than 20 marketed products</p>\n<p>LTS operates today from 5 sites: Netanya, Israel, Adrenarche, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA, and Shanghai, China.</p>\n<p> We are looking for an excellent Process validation &amp; NPI engineer </p>\n<p> to join our team in Israel.</p>\n<p>The position is hybrid - 4 days a week from the office, and 1 day from home.</p>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Job Description:</span></p>\n<p><br><br></p>\n<p>As a Medical Devices Process Validation Engineer, your primary responsibility is to ensure the compliance, reliability, and functionality of medical devices throughout the product lifecycle. You will play a crucial role in developing and executing validation protocols, conducting testing activities, and collaborating with cross-functional teams to guarantee the quality and safety of medical devices in accordance with regulatory standards.</p>\n<p> </p>\n<ul>\n<li>Design validation process for manufacturing jigs and tools – from manual jigs to fully automated manufacturing system.</li>\n<li>Compose protocols, execute procedures and write detailed reports for various validation activities – IQ\\OQ\\PQ</li>\n<li>Design, write, perform and document test method and software validation for testing devices and software.</li>\n<li>Participate in departmental tasks of manufacturing engineering processes under medical devices standards – products and process work instructions, maintaining, problem solving, design reviews presentations, and critical/root cause analysis.</li>\n<li>Work closely with R&amp;D, Quality Assurance, Regulatory Affairs, supply chain and other departments to lead new products process validations.</li>\n</ul>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Job Requirements:</span></p>\n<p> </p>\n<ul>\n<li><span style=\"font-weight: bold\">Education:</span> BSC in Biomedical/Mechanics/Biotechnology/Materials Engineering</li>\n<li><span style=\"font-weight: bold\">Job skills:</span>\n<ul>\n<li>Experience of 1-3 years in medical device industry - an advantage</li>\n<li>Previous experience in medical device validation or a related field, regulated environment, following development standards- an advantage</li>\n<li>knowledge of regulatory requirements for medical devices</li>\n<li>Testing of HW, SW, and mechanical sub-systems</li>\n<li>Experience with sterilization, reliability, and biocompatibility testing - Advantage</li>\n<li>Proven analytical, problem-solving, and troubleshooting skills</li>\n<li>Detail-oriented with a commitment to producing high-quality documentation processes.</li>\n</ul>\n</li>\n<li><span style=\"font-weight: bold\">Computer skills:</span>\n<ul>\n<li>Full control of all MS Office applications.</li>\n</ul>\n</li>\n<li><span style=\"font-weight: bold\">Language skills:</span> Fluent English – written and spoken.</li>\n<li><span style=\"font-weight: bold\">Personality:</span>\n<ul>\n<li>Responsible, motivated, meticulous, proactive, analytical mind, creative, expressive, excellent organizational skills, friendly.</li>\n</ul>\n</li>\n</ul>",
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