Engineer I/II (Pharma Operations)

<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>

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/

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Full time

Overview: <p>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.</p> <p>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;<em>inject</em><sup>&reg;</sup>&nbsp;device in September 2018 and iStent&nbsp;<em>inject</em><sup>&reg;</sup>&nbsp;W in September 2020.</p> <p>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.</p> <p>Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol &ldquo;GKOS&rdquo;. Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.<br /><br /><br />Job Description<br /><br />Responsible for manufacturing of development, pilot, clinical, verification/validation, stability study campaigns, and commercial production whether internal or at CMO (hands-on as needed).</p>
Responsibilities: <ul> <li>Responsible for troubleshooting and performing investigations for process and equipment.</li> <li>Responsible for the technology transfer package, including supporting data and reports.&nbsp;</li> <li>Coordinates internal and external activities and technicians to support our manufacturing campaigns including all component and final product deliverables for accuracy and schedule.</li> <li>Responsible for ensuring all pharma product development, manufacturing regulations, and quality requirements are met.</li> <li>Partner with Quality to ensure the Quality System (NCRs, deviations, CAPA, supplier notification (SCAR), ECOs, change controls, etc) documents appropriately comply with pharma product regulations.</li> <li>Responsible for equipment, process, and product verifications and validations (IQ, OQ, PQ, pFMEA, MVP, and PV).</li> <li>Support the stability studies for the pharma projects</li> <li>Represents the Operations group on pharma project teams</li> <li>Develop robust manufacturing processes that meet Corporate/Operations objectives for cost, quality, manufacturability,&nbsp;vendor quality, capacity, robustness, simplicity, validation, through put, etc., while meeting all regulatory, quality, and commercial requirements.</li> <li>Partner with R&amp;D to drive process improvements.</li> <li>Requires domestic travel of up to 3 weeks at a time during off-site campaigns.</li> </ul>
Requirements: <ul> <li>Clean room GMP/GLP environments (ISO 5-ISO 8)</li> <li>Strong combination of technical, business, and project management skills</li> <li>Developing processes, equipment, specifications, procedures, training, etc. at pilot/ clinical/commercial scale(s)</li> <li>Working with Purchasing/Supply Chain/Materials Management groups and component/API/excipient/raw material vendors to&nbsp;manage pharmaceutical component purchasing, inventory, and manufacturing supply.</li> <li>Organization and authoring of documentation (development, manufacturing, validations, studies, builds, components, etc.) that meets pharma and medical device GMP requirements in preparation for submission filings</li> <li>Success in developing scaled up process/equipment and transfer from Pilot to Clinical/Commercial Production.</li> <li>Providing cGMP and GDP manufacturing documentation and hands-on training for operations</li> <li>Assist with equipment selection/qualification</li> <li>CAD or Visio (drawings, flowcharts) experience is a plus</li> <li>Minitab or JMP (statistical analysis) experience is a plus</li> <li>Design of Experiments (DOE) experience is a plus</li> <li>To be successful in this role, the Pharmaceutical Engineer should have a Bachelor&rsquo;s degree in Engineering or Science with 6 months - 2 years of industry experience. Pharmaceutical or Biotechnology experience is preferred.<strong>&nbsp;</strong>Medical device experience is a plus.</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 paid 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 has been named one of the Top Workplaces by the Orange County Register for the past 3 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>