Sr. Manufacturing Engineer (Pharma) San Clemente, CA

Role: Senior Engineer I, Pharmaceutical, focusing on development, pilot, clinical, and commercial manufacturing of pharmaceutical/combination products. Responsibilities: manufacture various campaign types internally and at CMOs; troubleshoot processes/equipment; develop and validate manufacturing processes, equipment, and documentation (DHR, MBR, SOPs); support submissions; ensure compliance with pharma regulations and quality systems; participate in technology transfer and stability studies. Qualifications: Bachelor's in Engineering or Science; 5-8 years GMP experience in pharma/biotech; experience in GMP/GLP clean room environments; skills in process development, equipment, validation, and documentation; proficiency with CAD tools (SolidWorks, Visio), statistical analysis (Minitab, JMP), and DOE. High-Value: GMP/GLP manufacturing, process validation (IQ, OQ, PQ), combination products, clinical and commercial production, documentation for regulatory filings, technical leadership in process scale-up and transfer. WorkSetup: based in San Clemente, CA; limited guidance, leading projects and investigations independently.