Sr. Engineer, II Pharmaceutical

    • San Clemente, CA

Job Description
The Sr. Specialist/Associate Manufacturing Engineer, II Pharmaceutical position, based in San Clemente, CA will report to the Director of Pharmaceutical Operations and support internal and external (CMO) pilot (engineering runs/non-standard builds), clinical, and commercial pharmaceutical manufacturing. This will be a hands-on role partnering with technicians to manufacture as needed.

• Responsible for meeting all drug product development and manufacturing regulations and quality requirements. Partner with Quality to ensure that documentation complies with pharmaceutical drug regulations.
• Responsible for completing clinical and stability supply campaigns, as well as additional builds as needed for PK, Tox, and all other /product needs.
• Responsible for initial commercial production whether internal or at CMO.
• Manages final product deliverables for accuracy and schedule, to support stability studies, validations, clinical supplies, research needs, methods development and validation, special studies, samples, etc.
• Responsible for sterilization, package integrity and equipment validations for assigned pharmaceutical production projects and equipment
• Represents Operations on drug project teams and develops robust manufacturing processes meeting Corporate objectives for quality
• Partner with R&D to drive formulation and process improvements prior to scale up.
• Manages the tech transfer process from R&D to Pilot and Pilot to Clinical and Commercial Operations.
• Supports Quality events: investigations, deviations, and non-conformances.
• May require domestic travel of up to 3 weeks at a time during off-site operations (CMO)
• Senior Level: 8+ years direct commercial GMP experience within a pharmaceutical or biotechnology environment
• Full working knowledge of 21CFR Part 210/211 and other regulatory guidelines (ICH, WHO, EU, etc.)
• Knowledge of principles of drug process scale up and optimization for commercialization
• Knowledge of equipment, facility, and utility validation (IQ/OQ/PQ and CSV)
• Working knowledge of aseptic manufacturing processes
• Knowledge of principles of drug process scale up and optimization for commercialization
• Pharmaceutical process validation experience (MVP and PVP authoring, execution, and reporting) with continuous process verification (CPV) trending and reporting
• Attention to detail and accuracy
• Team player
• Good written/oral communicator
• Able to thrive in a small, entrepreneurial environment
• Must be organized and able to coordinate activities with internal departments and outside vendors
• Ability to effectively negotiate and build collaboration
• Proficient in computer skills (e.g. Word, Excel, Power Point)
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

• Bachelor's degree, in a Biology, Chemistry, or Engineering field. Advanced degrees or qualifications desirable.

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.

About Us
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness.

The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.

The company's second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.

In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.

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