Sr. Engineer I, 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.

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Full time

Overview: <p>The&nbsp;<strong>Senior Engineer/Specialist I/II, Operations Pharmaceutical,</strong>&nbsp;based in San Clemente, CA is responsible for development/pilot, clinical, and commercial manufacturing for pharmaceutical/combination products. The candidate supports the in-house manufacturing and contract manufacturing (CMOs) for development/pilot, clinical, and commercial campaigns.&nbsp;The candidate plays a key-role on the team including a hands-on role partnering with technicians to manufacture as needed. Additionally, the candidate will partner with R&amp;D, CMC, QA, and Regulatory on the following:</p> <ul> <li>Development/study protocols, execution, and reports</li> <li>Execute equipment and facility qualification</li> <li>Technology transfer</li> <li>Device History Record (DHR) and Master Batch Record (MBR) authoring and revisions</li> <li>Standard Operating Procedures (SOP) and Work Instructions (WI) authoring and revisions</li> <li>Support submission filings</li> </ul>
Responsibilities: <ul> <li>Responsible for manufacturing of development, pilot, clinical, verification/validation, stability study campaigns, and commercial production whether internal or at CMO (hands-on as needed).</li> <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 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>Execute equipment selection/qualification</li> <li>SolidWorks 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 candidate should have a Bachelor&rsquo;s degree in Engineering or Science with&nbsp;4-8 years direct clinical and/or commercial GMP experience within a pharmaceutical or biotechnology environment</li> </ul>