Lead Manufacturing Technician - Pharma

Glaukos Corporation; San Clemente (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Glaukos Corporation in San Clemente, CA is seeking a Lead Manufacturing Technician to oversee scheduled production, manage preventive maintenance, and ensure cGMP/GDP documentation. The role includes opening/closing jobs in the MRP/Oracle system, and coordinating with Management and Engineering.

Responsibilities include supervising technicians, managing schedules, and ensuring quality while maintaining GMP/QSR/GDP-compliant documentation and equipment maintenance programs.

Qualifications

• Industry (medical device, pharmaceutical, and/or biotechnology) and educational experience.
• 8–10 years’ experience with high school diploma
• 6–8 years’ experience with associate degree in science or engineering
• 4–6 years’ experience with bachelor’s degree in science or engineering
• Highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards.

Responsibilities

• Manage the operation schedule, project schedule, and adjust the schedule and resources accordingly
• Supervise production technician(s) to optimize quality and output
• Perform all activities outlined for a Manufacturing Technician as needed
• Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP)
• Manage Oracle to open and close jobs
• Manage inventory requests and reconciliation for accuracy
• Revise documentation to ensure accuracy and compliance
• Communicate feedback to engineering on Non-Standard Build Requests, Validation builds, Clinical builds, etc.

Skills

GDP & cGMP documentation

Quality system compliance

Production scheduling

Team supervision

Education

High school diploma

Associate degree in science or engineering

Bachelor’s degree in science or engineering

Tools

Oracle ERP

Job description

Job Description

Lead Manufacturing Technician, based in San Clemente, CA, will be responsible for the completion of the scheduled production and management of preventative maintenance. The Lead will ensure proper documentation (cGMP and GDP), open and close jobs in the MRP system, and provide feedback and updates to Management and Engineering. This position will also prepare components, build assemblies, and bulk drug formulations. All activities will be performed with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device good manufacturing practices (GMP) requirements.

Additional Tasks

• 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)
• Tracking clean room, environmental chambers, and equipment preventive maintenance (PMs)

Responsibilities

• Manage the operation schedule, project schedule, and adjust the schedule and resources accordingly
• Supervise production technician(s) to optimize quality and output
• Perform all activities outlined for a Manufacturing Technician as needed
• Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP)
• Manage Oracle to open and close jobs
• Manage inventory requests and reconciliation for accuracy
• Revise documentation to ensure accuracy and compliance
• Communicate feedback to engineering on Non-Standard Build Requests, Validation builds, Clinical builds, etc.

Qualifications

• Industry (medical device, pharmaceutical, and/or biotechnology) and educational experience.
• 8–10 years’ experience with high school diploma
• 6–8 years’ experience with associate degree in science or engineering
• 4–6 years’ experience with bachelor’s degree in science or engineering
• Highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards.

Equal Opportunity / EEO Statement

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.