Manufacturing Technician I

<p class="">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.<br /><br /><br /><strong>Base Salary Range: $31,000 - $44,900</strong></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: position summary,compensation,performance,assemble,prepare,process,organization,microsoft,execute,collect,experience,medical

Full time

Base Salary Range: $31,000 - $44,900

Overview: <p>The&nbsp;<strong>Manufacturing Technician I</strong>, based in San Clemente, CA will be responsible for the following:</p> <ul> <li>Prepare components and build assemblies</li> <li>Prepare bulk drug formulations</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> </ul>
Responsibilities: <ul> <li>Ability to 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> <li>Ability to perform basic calculation and data entry</li> <li>Ability to assemble, disassemble, and clean process equipment</li> <li>Ability to clean, etch, passivate, assemble, and inspect components</li> <li>Ability to process and assemble components in accordance with documented specifications and procedures</li> <li>Ability to prepare bulk drug formulation operations</li> <li>Ability to perform filling, capping and crimping operations</li> <li>Ability to perform packaging and labeling operations</li> <li>Ability to perform in-process inspection of assemblies and finished products in accordance with specification criteria</li> <li>Ability to perform validation activities (IQ/OQ/PQ/TMV/PV)</li> <li>Ability to perform routine equipment preventative maintenance (PM)</li> <li>Ability to coordinate with approved vendors the daily/weekly/monthly/quarterly additional activities, collect vendor certificates, and complete documentation</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: <p>To be successful in this role, you will need to have the following industry (medical device, pharmaceutical, and/or biotechnology) and educational experience.</p> <p>It is highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards.</p> <p><strong>Level - I</strong></p> <ul> <li>0 &ndash; 3 &nbsp;years&rsquo; experience with high school diploma.</li> </ul>