Senior Pharma Manufacturing Engineer: Impact & Growth

Glaukos Corporation; San Clemente (CA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Bonus eligibility

Medical/dental/vision

Stock options

401(k) Employer Match

Employee Stock Purchase Program

Generous time off

Paid holidays

Volunteer time off

Job summary

Glaukos Corporation in San Clemente, CA is seeking a Senior Engineer I, Pharmaceutical to lead development/pilot, clinical, and commercial manufacturing for pharmaceutical/combination products. The role supports in-house and contract manufacturing, partnering with R&D, CMC, QA, and Regulatory to advance protocols, qualification, tech transfer, and documentation.

You will execute process development and scales, troubleshoot processes/equipment, organize campaigns, ensure GMP and quality

Qualifications

• Bachelor's degree in Engineering or Science with 5-8 years GMP experience.
• Experience in clean room GMP/GLP environments (ISO 5-ISO 8).
• Strong technical, business and project management skills.
• Experience developing processes and tech transfer at pilot/clinical scale.
• Ability to author documentation for regulatory submissions.

Responsibilities

• Manufacture development, pilot, clinical, and commercial campaigns, in-house or at CMOs.
• Troubleshoot processes and equipment; perform investigations.
• Lead project milestones with approval from team/management.
• Coordinate internal/external activities and resources for campaigns.
• Ensure pharma product development, manufacturing regs and quality requirements.
• Partner with QA to ensure GMP documentation compliance.
• Perform verifications/validations (IQ, OQ, PQ; pFMEA, MVP, PV).
• Support stability studies and tech transfer activities.
• Develop robust processes meeting cost, quality, capacity and regulatory needs.

Skills

GMP experience

Project management

Technical leadership

Cross-functional coordination

Process development

Education

Bachelor's degree in Engineering or Science

Tools

SolidWorks

Visio

Minitab

JMP

Job description

Glaukos Corporation in San Clemente, CA is seeking a Senior Engineer I, Pharmaceutical to lead development/pilot, clinical, and commercial manufacturing for pharmaceutical/combination products. The role supports in-house and contract manufacturing, partnering with R&D, CMC, QA, and Regulatory to advance protocols, qualification, tech transfer, and documentation.

You will execute process development and scales, troubleshoot processes/equipment, organize campaigns, ensure GMP and quality