Manufacturing Technician II/III, (Pharma)

<strong>At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases&mdash;therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.<br /><br />Help put the next wave of disruptive technologies on the market. Work with a team that&rsquo;s dedicated to making a difference in the lives of patients worldwide.<br /></strong>

San Clemente, CA


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. <br /><br />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.<br /><br />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.

keywords: reporting,performance,prepare,assemble,process,organization,microsoft,execute,collect,education,experience

Full time

Overview: The&nbsp;<strong>Manufacturing Technician II/III,</strong>&nbsp;based in San Clemente, CA reports into the Global Operations organization and plays a key role in the manufacturing of Glaukos products. &nbsp;
Responsibilities: <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><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><strong>Education:</strong></p> <ul> <li><strong>Level II:&nbsp;</strong>3 &ndash; 6 years&rsquo; experience with high school diploma;&nbsp;2 &ndash; 4 years&rsquo; experience with associate degree in science or engineering;&nbsp;0 &ndash; 2 years&rsquo; experience with bachelor&rsquo;s degree in science or engineering.</li> <li><strong>Level III:&nbsp;</strong>6 &ndash; 8 years&rsquo; experience with high school diploma;&nbsp;4 &ndash; 6 years&rsquo; experience with associate degree in science or engineering;&nbsp;2 - 4 years&rsquo; experience with bachelor&rsquo;s degree in science or engineering.</li> </ul>