Sr. Quality Validation Engineer I at Glaukos Corporation in Boston, Massachusetts

Posted in Other 26 days ago.

Type: Full-Time





Job Description:

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.

The Quality Assurance, Senior Validation Specialist, based in Burlington, Massachusetts and reports directly to the Senior Manager of Quality. This role will be key in supporting the process development and validation activities at our contract manufacturing sites and assuring they are aligned with regulatory expectations as we transition from a clinical CMO to a Commercial CMO. The successful candidate’s primary role will be to oversee process development, process validation, equipment & facility qualification/validation and cleaning validation projects for our future Commercial Products.


QA, Senior Validation Specialist Position involves designing, executing and concluding manufacturing equipment qualification, manufacturing studies, process validation, operational and performance qualifications of equipment and utility systems, as well as writing SOPs where applicable.


Responsibilities:


·       Provide QA oversight of process development and validation activities for manufacturing equipment, utilities, depyrogenation and sterilization to support the manufacturing facility projects and keep the facility in a validated state.


·       Responsible for review/approval of commissioning documentation, validation/requalification protocols, reports and support records to ensure compliance with local procedures, timely resolution of documentation, compliance, and quality system issues.


·       Support the validation execution strategy and timeline with validation management and project team for manufacturing equipment, utilities, automation, and cleaning validation/requalification.


·       Review validation documents following established standards and templates, including but not limited to the following:


 


Validation plans including project plans and validation status lists.


Qualification / Validation Protocols and Summary Reports.


Standard Operating Procedures related to validation execution.


Risk Assessments and Impact Assessments.


Specification documentation


Qualification/validation protocols, eg IQ/OQ/PQ.


Provide oversight over validation testing as needed according to written procedures.


·       Review/approve validation discrepancy investigations and proposed corrective actions.


·       Engage in quality system continuous improvement initiatives to enforce the quality culture.


·       Provides technical input to process/validation deviations; provides assessments for change requests on direct impact systems; and identifies qualification requirements to ensure the validated state is maintained.


Requirements:


·       Excellent technical writing and verbal communication skills


·       Ability to read/interpret process development and characterization documents


·       Ability to work as part of a high performing team and collaborate effectively with staff at all levels.


·       Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.


·       Demonstrated ability to manage multiple activities while maintaining a high level of organization.


·       Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.


·       Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.


·       Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers under general supervision.


·       Ability to interpret and relate Manufacturing process, validation standards for implementation, and review to functional areas.


·       Good knowledge of Biopharmaceutical and process engineering.


·       Good understanding of cGMP guidelines applicable for US FDA.


·       Good understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements


Education:


·       Bachelor's degree from an accredited institution with five (5) years of pharmaceutical quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).


·       Master’s degree from an accredited institution with two (2) years of pharmaceutical quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).


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.