Lead Manufacturing Technician - Pharma

How will you make an impact?

The 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/close jobs in 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 will include performing the following:

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

What will you do?

• Manage the operation schedule, project schedule, and adjusts the schedule and resources accordingly
• Supervise production technician(s) to optimize quality and output
• Ability to perform all activities outlined for a Manufacturing Technician as needed
• Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP)
• Manages Oracle to open and close jobs
• Manages 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.

How will you get here?

To be successful in this role, you will need to have the following:

• 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
• It is highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards.

#GKOSUS

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

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.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.