Manufacturing Technician III, Pharmaceutical

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

San Clemente, CA


<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4>

keywords: execute,performance,assemble,prepare,process,teamwork,organization,microsoft,experience,skills,knowledge

Full time

Overview: <ul> <li>Follow, execute, and adhere to documentation in accordance with cGMP, QSR, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), BRs, and DHRs.</li> </ul>
Responsibilities: <ul> <li>Work within a team to complete assembly in various work stations on the production floor.</li> <li>Perform basic calculation and data entry.</li> <li>Prepare components and build assemblies.</li> <li>Perform filing, capping, and crimping operations.</li> <li>Perform packaging and labeling operations.</li> <li>Perform sampling.</li> <li>Perform visual inspections.</li> <li>Perform documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR).</li> <li>Perform and/or track clean room, environmental chambers, and equipment preventive maintenance (PMs).</li> <li>Perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device good manufacturing practices (GMP) requirements.</li> <li>Assemble, disassemble, and clean process equipment.</li> <li>Clean, etch, passivate, assemble, and inspect components.</li> <li>Process and assemble components in accordance with documented specifications and procedures.</li> <li>Perform in-process inspection of assemblies and finished products in accordance with specification criteria.</li> <li>Perform validation activities (IQ/OQ/PQ/TMV/PV).</li> <li>Perform routine equipment preventative maintenance (PM).</li> <li>Uses Microsoft Word, Excel and Oracle to complete document reviews, training, check inventory, and create forecasts.</li> <li>Organize and clean the work areas: clean room, production areas, laboratory areas, and warehouse.</li> <li>Perform additional duties and projects as required to facilitate Operations, Engineering, Clinical, and Quality Assurance goals and objectives.</li> </ul>
Requirements: <ul> <li>Level II: 2 &ndash; 5 years&rsquo; manufacturing experience with high school diploma; 0+ years&rsquo; experience with associate degree in science or engineering.</li> <li>Level III: 4 &ndash; 7 years&rsquo; manufacturing experience with high school diploma; 2+ years&rsquo; experience with associate degree in science or engineering; 0+ years&rsquo; experience with bachelor&rsquo;s degree in science or engineering.</li> <li>Strong communications skills.</li> <li>Well-Organized.</li> <li>Familiarity with Microsoft Word, Excel &amp; PowerPoint.</li> </ul>