Lead Manufacturing Technician - 2nd shift

GLAUKOS #DareToDomore Lead Manufacturing Technician (2^nd Shift) - San Clemente, CA

Founded in 1998, Glaukos is publicly traded ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Our global headquarters is in Aliso Viejo, California, and we have additional locations in the United States, Canada, United Kingdom, Germany, Japan, Australia and Brazil.

How will you make an impact?

The Lead Manufacturing Technician will be directly responsible for performing all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality management system (QMS) medical device good manufacturing practices (GMP) requirements.

Must also be able to perform:

• kitting operations (measure out components or raw materials)
• activities under a microscope
• filing, capping, and crimping operations
• packaging and labeling operations
• sampling
• visual inspections
• documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)

Other duties will include:

• Prepare components and build device assemblies
• Prepare bulk drug formulations
• Assist leads on daily activities
• Train technicians
• Request and review documentation (including engineering builds)
• Knowledge of GDP, cGMP, and QMS
• Support R&D initiatives in Aliso Viejo
• Support technology transfer from R&D to Ops
• Support engineering initiatives
• Ability to perform all the activities above
• Real-time review of all executed documentation on the floor
• Oversee and assign daily production activities
• Ensure proper documentation (cGMP and GDP)
• Open/close work orders in Maximo and the enterprise resource planning (ERP) system
• Oversee inventory on a daily basis in the ERP system
• Ability to address and resolve daily issues on the manufacturing floor
• Provide feedback and escalation to leadership
• Maintain production yield database
• Provide support for QMS including non-conformances (NCs), corrective and preventative actions (CAPAs), and change controls (CCs))
• Additional tasks as required

What will you do?

• Maintain proper cleanroom environment (including gowning, room cleaning, and supplies)
• Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches.
• Perform basic calculation and data entry
• Ability to assemble, disassemble, and clean process equipment
• Ability to clean, etch, passivate, assemble, and inspect components
• Process and assemble components in accordance with documented specifications and procedures
• Prepare bulk drug formulation operations
• Perform filling, capping and crimping operations
• Perform packaging and labeling operations
• Perform in-process inspection of assemblies and finished products in accordance with specification criteria
• Organize and clean the work areas
• Ability to perform validation and qualification activities (IQ/OQ/PQ/PV)
• Maintain the operation schedule and allocate resources accordingly
• Oversee daily production activities
• Review all documentation and ensure completion following cGMP, QMS, and GDP guidelines.
• Use of Word, Excel and ERP to complete document reviews, training, and inventory
• Maintain on the floor inventory for accuracy
• Revise documentation to ensure accuracy and compliance
• Communicate feedback to engineering on non-standard build requests, validation builds, clinical builds, etc.

How will you get here?

• High School Diploma Required
• 6+ years of related experience in the medical device, pharmaceutical, and/or biotechnology industries, or a AA with 5+ years of experience or a bachelor's degree with 4+ years of experience
• It is highly desirable to have experience working in and maintaining a cleanroom in accordance with GDP and cGMPs standards.