Lead Manufacturing Technician (2nd Shift)

<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>

United States

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: leadership,maintenance,performance,management,prepare,database,production,quality assurance,verify,accounting,communication,publishing,experience,pharmaceutical,education

Full time

Overview: The&nbsp;<strong>Lead</strong>&nbsp;<strong>Manufacturing Technician, 2nd Shift</strong>, based in San Clemente, CA you will be responsible for building and preparing components, subassemblies and top-level assemblies, completes documentation and data input into an MRP system and/or Batch Records (BRs) and Device History Record (DHR). You will also be responsible for preventive maintenance on specific equipment and documentation for department manager review and approval as well as supporting and participating in the maintenance of the clean room and environmental chambers, manufacturing equipment and keeping cleanliness of the clean room in accordance with cGMPs/QSR requirements.
Responsibilities: <ul> <li>Prepare components and build assemblies; prepare&nbsp;bulk drug formulations.</li> <li>Perform filing, capping, and crimping operations; perform packaging and labeling operations; perform sampling and visual&nbsp;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>Completion of the scheduled production and management of the preventative maintenance.</li> <li>Ensure proper documentation (cGMP and GDP)</li> <li>Open/close jobs in MRP system.</li> <li>Provide feedback and updates to Management and Engineering.</li> <li>Manage the operation schedule, project schedule, and adjusts the schedule and resources accordingly.</li> <li>Supervise production technician(s) to optimize quality and output.</li> <li>Ability to perform all activities outlined for a Manufacturing Technician as needed.</li> <li>Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP).</li> <li>Manages Oracle to open and close jobs.</li> <li>Manages inventory requests and reconciliation for accuracy.</li> <li>Revise documentation to ensure accuracy and compliance.</li> <li>Communicate feedback to engineering on Non-Standard Build Requests, Validation builds, Clinical builds, etc.</li> </ul>
Requirements: <ul> <li>High school diploma; Bachelor's degree preferred.</li> <li>Pharmaceutical&nbsp;and/or biotechnology&nbsp;experience preferred.</li> <li>Experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards highly desirable.</li> <li>4 - 6 years&rsquo; experience.</li> </ul> <p><em><strong>***Glaukos compensation ranges were not directly given to LinkedIn and are estimated ranges from similar roles outside of Glaukos. Glaukos provides competitive industry and functional compensation. Please apply and inquire with your recruiter.***</strong></em></p>