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

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: teamwork,quality assurance,engineering,procedure,support,research,process,support,operations,compliance,quality assurance,technology,develop,travel,research,technical,purchasing,success,organization,design,degree,procedure,technology,communication,analysis

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>