Senior Computer Systems Validation Engineer

Requirements:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
• Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered.
• Must have technical knowledge of IT infrastructure, software engineering, programming, databases and data integrations.
• Experience working in modern system environments utilizing CI/CD pipelines or automated release processes.
• Strong hands-on experience validating GAMP 5 systems for biotech manufacturing.
• Deep understanding of FDA 21 CFR Part 11, Part 210, Part 211, Annex 11, data integrity requirements, and risk-based validation methodologies.
• Strong technical writing skills and ability to create comprehensive validation documentation.
• Ability to communicate validation risks and requirements clearly to IT and Quality stakeholders.
• Other combinations of education and/or experience may be considered.
• Preferred Qualifications:
• Hands-on experience validating cloud based GxP systems, specifically Azure.
• Familiarity with infrastructure as code frameworks like GitHub, Terraform etc.
• Experience applying CSA principles to custom data applications in GxP cloud.
• Microsoft Azure or similar technical certifications.
• Equal Opportunity
• We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
• Recruitment Fraud Notice
• Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.