Senior Software Validation Engineer

San Francisco
Quality
Full-time
At Vineti, we create solutions that scale for healthcare. Specifically, we develop software products that help deliver personalized medicines like cures for cancer. This includes creating a service-oriented, auditable, software platform to support multiple client-facing applications in a regulated market.  Highly impactful and mission critical!
 
We are looking for a Senior Software Validation Engineer to be responsible for implementing all Software Quality functions to meet FDA requirements and execute software validation. 

WHAT YOU’LL BE DOING:

    • Work with clients to define and implement validation requirements
    • Define and document testing requirements for IQ/OQ/PQ
    • Write/Update/Review/Approve SOPs and QA procedures
    • Write/Update/Review/Approve QA documents needed to support the business
    • Support audits of Vineti
    • Support Software Development
    • Support and Witness test protocol execution

THE FOLLOWING EXPERIENCE AND SKILLS ARE IMPORTANT TO US:

    • Minimum of 5 years of pharmaceutical or biotechnology industry experience
    • Minimum 3 years in a quality assurance/regulatory compliance position
    • Experience and knowledge of Regulatory Software Development Life Cycle (SDLC).
    • Working knowledge of Quality Management Systems (QMS)
    • BS/BA Bachelor’s Degree in Business and/or Life Sciences or demonstrated experience 
    • Ability to collaborate and partner with various internal product teams
    • Must be disciplined and detail oriented
    • Strong written and oral communication skills
    • Comfort with a fast-paced environment and changing requirements
    • Ability to flourish with minimal guidance, be proactive, and handle uncertainty and ambiguity

BONUS SKILLS:

    • Specific experience deploying a Cloud based, GAMP 5 specific Regulatory application
    • Experience with a Quality Management Systems Vendor (QMS)
    • Knowledge of Document Management 

COMPANY CULTURE AND BENEFITS:

    • Mission driven and passionate about making things that matter in healthcare and solving complex problems in personalized medicine
    • We’re a fast growing company backed by major investors
    • Equity
    • Health and dental benefits for you and competitive coverage for your family
    • Flexible work hours
    • Open vacation policy - take time when you need it
    • We support remote work when needed
    • Opportunities for growth