COMPUTER SYSTEMS VALIDATION MANAGER

Gritstone Oncology, Inc.

Emeryville, CA

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Gritstone bio is a public, next-generation personalized cancer and infectious immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The company’s goal is to identify and deploy neoantigens for novel treatments of cancer and infectious diseases. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients.

Position Summary

Gritstone bio., Inc. is seeking a talented and self-motivated Computer System Validation Manager/Senior Manager to join the IT Team. This role will be central to the support, management and validation of our LIMS programs and other GxP regulated applications. This role will interact with both business and IT resources to coordinate operational validation activities. An ideal candidate will be an individual who has a solid understanding of validation practices, can work independently with the both the business, IT and Quality organizations to manage all in scope validation deliverables as required by our software development practices.

Responsibilities
  • Partner with the respective business functions (R&D, Manufacturing, and Quality) to implement IT capabilities of Gritstone therapies through commercialization.
  • Lead user requirements and design workshops for the collection of business requirements, stories and epics.
  • Both author and at times facilitate the documentation of all required deliverables supporting the validation lifecycle for systems with regulatory impact.
  • Engage with the cloud engineering teams to support the development, implementation and integration of Gritstone applications.
  • Participate in the authoring of validation deliverables for user acceptance testing and procedural documents as required.
  • Provide technical assistance to end-users along with holding training sessions on user adoption
  • Utilize best practices and hands-on experience within a Biotech, Pharma, of Life Sciences company
  • Prioritize the execution of new or enhanced systems and perform daily support as needed

Minimum Education/Experience
  • Bachelor’s degree (or equivalent) in scientific discipline, engineering or computer science.
  • Minimum of 4 years’ experience within life sciences supporting validated applications in a lab or manufacturing environment.
  • 4-8 years of relevant computer system validation experience supporting both IT SaaS and or benchtop laboratory applications
  • Good knowledge of software development lifecycle as it pertains to validation and validation deliverables.
  • Good knowledge and understanding of 21CFR, part 11 as well as regulations around GMP and other predicate rules.
  • Good communication, presentation and interpersonal skills
  • Good writing skills to support validation and SOP documentation
  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment.
  • Self-motivated, self-disciplined and able to function independently as well as part of a team.
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills.
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)