Manufacturing Technician II

<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.</p> <br /><strong>Base Salary Range: $35,600 - $51,700</strong>

San Clemente, CA

Glaukos

<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> https://www.glaukos.com/

keywords: position summary,compensation,abilities,duties,documentation,education & experience

Full time

Base Salary Range: $35,600 - $51,700

Overview: <div id="overview" class="job-summary-section ng-scope"> <div class="full-text ng-binding"> <p><strong>What will you do?</strong></p> <p>The Manufacturing Technician II, based in San Clemente, CA, will 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.</p> </div> </div> <div class="ng-scope">&nbsp;</div> <div class="ng-scope">&nbsp;</div> <div id="responsibilities" class="job-summary-section ng-scope">&nbsp;</div>
Responsibilities: <p><strong>What will you do?</strong></p> <p>The&nbsp;<strong>Manufacturing Technician II</strong>, based in San Clemente, CA will be responsible for the following:<br />Prepare components and build assemblies</p> <ul> <li>Prepare bulk drug formulations</li> <li>Perform the following:&nbsp;</li> <li>Filing, capping, and crimping operations</li> <li>Packaging and labeling operations</li> <li>Sampling</li> <li>Visual inspections</li> <li>Documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)</li> <li>Track clean room, environmental chambers, and equipment preventive maintenance (PMs)</li> </ul> <p>Additional responsibilities will include:&nbsp;</p> <ul> <li>Perform basic calculation and data entry; Assemble, disassemble, and clean process equipment; Clean, etch, passivate, assemble, and inspect components</li> <li>Process and assemble components in accordance with documented specifications and procedures and prepare operations for:&nbsp;</li> <li>Bulk drug formulation&nbsp;</li> <li>Filling, capping and crimping&nbsp;</li> <li>Packaging and labeling&nbsp;</li> <li>Perform in-process inspection of assemblies and finished products in accordance with specification criteria&nbsp;</li> <li>Ability to perform validation activities (IQ/OQ/PQ/TMV/PV) as well as routine equipment preventative maintenance (PM)</li> <li>Coordinate with approved vendors daily/weekly/monthly/quarterly additional activities, collect vendor certificates, and complete documentation</li> <li>Use 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.&nbsp;</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 - II&nbsp;</strong></p> <ul> <li>3 &ndash; 6 years&rsquo; experience with high school diploma</li> <li>2 &ndash; 4 years&rsquo; experience with associate degree in science or engineering</li> <li>0 &ndash; 2 years&rsquo; experience with bachelor&rsquo;s degree in science or engineering</li> </ul> <br /> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Check out our profile on The Muse to get an inside look at our company culture. Glaukos Corporation has been Certified as a Great Place to Work the last two years!</p> <p>Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.</p>