Glaukos Corporation
Lead Manufacturing Technician (2nd Shift)
Glaukos Corporation, San Clemente, California, us, 92674
GLAUKOS #DareToDomore Lead Manufacturing Technician (2nd 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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr