Sr. Manufacturing Engineer; Pharma San Clemente, CA

The Senior Engineer I, Pharmaceutical, 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. The candidate plays a key role on the team, partnering with technicians to manufacture as needed. Additionally, the candidate will partner with R&D, CMC, QA, and Regulatory on the following:

• Development/study protocols, execution, and reports
• Execute equipment and facility qualification
• Technology transfer
• Device History Record (DHR) and Master Batch Record (M ) authoring and revisions
• Standard Operating Procedures (SOP) and Work Instructions (WI) authoring and revisions
• Support submission filings

• Manufacture development, pilot, clinical, verification/validation, stability study campaigns, and commercial production either internally or at CMO (hands‑on as needed).
• Troubleshoot and perform investigations for process and equipment.
• Participate in development of completed project plans with defined milestones, which are defined by the project engineer but approved by the team and management.
• Organize internal and external activities and technicians to support manufacturing campaigns, ensuring all component and final product deliverables are accurate and on schedule.
• Ensure all pharmaceutical product development, manufacturing regulations, and quality requirements are met.
• Partner with Quality to ensure the Quality System (NCRs, deviations, CAPA, supplier notification (SCAR), ECOs, change controls, etc.) documents appropriately comply with regulatory requirements.
• Responsible for equipment, process, and product verifications and validations (IQ, OQ, PQ, pFMEA, MVP, and PV).
• Support the stability studies for the pharmaceutical projects.
• Apply fundamental and advanced engineering principles, concepts, theories, and techniques to solve complex problems related to product development, design, and manufacturing while following company standard practices and procedures and related specifications.
• Develop robust manufacturing processes that meet corporate/operations objectives for cost, quality, manufacturability, vendor quality, capacity, robustness, simplicity, validation, throughput, while meeting all regulatory, quality, and commercial requirements.

• Bachelor’s degree in Engineering or Science with 5‑8 years of direct clinical and/or commercial GMP experience within a pharmaceutical or biotechnology environment.
• Experience in clean‑room GMP/GLP environments (ISO 5‑ISO
  8).
• Strong combination of technical, business, and project management skills.
• Developing processes, equipment, specifications, procedures, training, etc. at pilot/clinical/commercial scale(s).
• Working with Purchasing/Supply Chain/Materials Management groups and component/API/excipient/raw material vendors to manage pharmaceutical component purchasing, inventory, and manufacturing supply.
• Lead projects and investigations with limited guidance.
• Organize and author documentation (development, manufacturing, validations, studies, builds, components, etc.) that meets pharmaceutical and medical device GMP requirements in preparation for submission filings.
• Success in developing scaled‑up process/equipment and transfer from Pilot to Clinical/Commercial Production.
• Provide cGMP and GDP manufacturing documentation and hands‑on training for operations.
• Ability to author V&V and some DHF deliverables with guidance.
• Solid Works or Visio (drawings, flowcharts) experience.
• Minitab or JMP (statistical analysis) experience.
• Design of Experiments (DOE) experience.

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 time off and paid holidays, and time‑off to volunteer in the community.

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.