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

Glaukos

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. https://www.glaukos.com/

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>