Job DescriptionHow will you make an impact? We are seeking a
Senior Systems Validation Analyst to ensure compliance with GxP (Good Practice) regulations for enterprise business and IT systems in the pharmaceutical and medical device industries. This role is critical in maintaining the integrity, reliability, and quality of data and processes that impact product safety, efficacy, and regulatory compliance.
- Play a key role in ensuring regulatory compliance and product quality.
- Work in a high-impact, innovation-driven environment.
- Collaborate with cross-functional teams in a leading pharmaceutical/medical device organization.
What will you do? - Develop & Execute Validation Strategies for computerized systems, IT infrastructure, and GxP processes.
- Create & Maintain Documentation (validation plans, risk assessments, test protocols, and reports) aligned with FDA, EMA, ICH, and cGMP regulations.
- Perform Validation Protocol Execution and manage deviation mitigation/remediation activities.
- Assess Change Control Requests to ensure validation compliance.
- Collaborate with QA Teams to uphold validation integrity and regulatory compliance.
- Apply Risk Management Principles to mitigate potential validation risks.
- Train & Support Teams on validation requirements and best practices.
- Support Internal & External Audits related to validation activities.
How will you get here?Required: - Bachelor's Degree in IT, Biology, Chemistry, Pharmacy, Engineering, or a related field.
- 5+ years of experience in validation within pharmaceuticals, biotech, or medical devices.
Strong understanding of GxP regulations (GMP, GLP, GCP) and regulatory guidelines (FDA, EMA, ICH). - Experience with validation methodologies, risk-based validation, and computerized systems validation (CSV).
- Proficiency in document management, change control, and lifecycle management systems.
- Strong analytical, organizational, and communication skills.
- Self-motivated, results-driven, and able to work independently.
Preferred Skills: - Certified Validation Professional or equivalent work experience.
- Experience with CSA validation processes.
- Knowledge of Quality Management Systems (QMS) and best practices.
- Familiarity with Oracle Cloud SCM and Veeva Vaults.
About Us 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.