Manufacturing Technician I — Second Shift, GMP

Cordis; Irvine (CA); Sur place; USD 30 000 - 38 000; Plein temps

Résumé du poste

Cordis in Irvine is seeking a Manufacturing Engineer Technician I (Second Shift) to support the development and manufacturing of drug-device products. You will help build robust processes, transfer tech from development to production, and ensure quality and GMP-compliant operations.

The role requires 2+ years in medical device/pharma, a HS diploma, English fluency, and ability to lift 25 lbs. This on-site position offers growth in a collaborative environment.

Qualifications

• HS diploma or GED.
• 2+ years in medical device or pharmaceutical field or equivalent.
• Strong verbal and written communication skills.
• Excellent organization and follow-up with attention to detail.
• Ability to make independent decisions.
• Knowledge of validation/verification, Gage R&R, FDA QSR and GMP.
• SolidWorks CAD knowledge is a plus.
• Fluent in English.

Responsabilités

• Assist in developing manufacturing processes for existing products.
• Incorporate robust transition from development to full-rate production; stabilize processes.
• Develop and qualify new tooling and equipment.
• Verify and validate processes, machines per procedures (IQ/OQ/PQ).
• Troubleshoot issues and implement corrective/preventive actions.
• Manage hazardous waste handling per CAL-OSHA/EPA regulations.
• Oversee fabrication schedules and optimize workflow within resources.
• Manage end-to-end inventory and safety stock for fabrication components.
• Perform in-process sampling, inspection, and particle testing.
• Maintain GMP-compliant processing and packaging of microsphere batches.

Connaissances

Verbal and written communication

Organization and follow-up

Independent decision-making

Analytical/problem-solving

Project management

Fluent in English

FDA QSR & GMP knowledge

Problem solving

Formation

HS diploma or GED

Associate's degree or equivalent

Outils

SolidWorks

CAD software

Description du poste

Cordis in Irvine is seeking a Manufacturing Engineer Technician I (Second Shift) to support the development and manufacturing of drug-device products. You will help build robust processes, transfer tech from development to production, and ensure quality and GMP-compliant operations.

The role requires 2+ years in medical device/pharma, a HS diploma, English fluency, and ability to lift 25 lbs. This on-site position offers growth in a collaborative environment.