The Sr Manufacturing Technician will be responsible for the manufacturing and in-process testing for IVD products at the San Juan Capistrano facility. Such activities will include among others:

• Manufacturing of product, 
• troubleshooting, 
• Equipment maintenance
• metrics trending, 
• execution of validation activities and 
• document creation and revisions

• Manufacturing and assembly of IVD products and kits, and coordination of manufacturing schedule for SJC site manufactured products.
• Creation and revision of label templates in bartender.  Implementation of label templates ensuring adequate process controls.
• Conduct process validation runs as part of commercial manufacturing support. 
• Revision and creation of manufacturing related procedures.  Endure adequate and accurate documentation of device history records, instrument records, PM records etc.
• Support implementation of continuous improvement activities.
• Execute equipment preventive and corrective maintenance to keep production equipment operational. 
• Help with troubleshooting of problems within the manufacturing process. 
• Create reports and analyze production data / information.
• Ensure all manufacturing related areas are kept organized and clean and in good housekeeping conditions (inclusive of materials areas)
• Ensure full compliance with IVD FDA and ISO requirements.
• Ensure all required training is done on time.

Required Work Experience: 

• Minimum of five (5) years’ experience in Laboratory and/or Manufacturing 

Preferred Work Experience: 

• Minimum of five (5) years’ experience in IVD / pharmaceutical or medical device in Manufacturing or Laboratory
• Laboratory Technician

Physical and Mental Requirements: 

• Prolonged Pipetting and ELISA plate set ups
• Focused attention
• Prolonged sitting

Knowledge: 

• FDA and ISO regulations and requirements 
• Quality processes and systems
• Manufacturing / Laboratory process and systems

Skills: 

• Good record keeping skills
• Laboratory analytical skills (pipetting, reagents, etc.)
• Instrumentation skills (plate reader/washers, incubation ovens, shakers, etc.) 
• Analytical and problem-solving skills 
• PC literate (excel, word, Minitab, PowerPoint, etc.)
• Understand the requirements of a QSRs Quality System. ISO-13485 and GMP environment.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.