Senior Validation Engineer

South San Francisco, CA, United States
Feb 02, 2021
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches.

Sutro Biopharma, Inc. is looking for a Senior Validation Engineer to join its multidisciplinary research and development team. You will be working to develop new processes to maximize our technology and enhance our internal and collaborative product development initiatives in a fast-paced environment.

  • Responsible for supporting start-up and ongoing validation activities associated with Sutro's cGMP Manufacturing Facility in accordance with current regulatory and industry standards.
  • Execute validation projects and coordinate activities between Sutro (Manufacturing, Facilities, Quality Control and Quality Assurance Departments) and Third Parties.
  • Contribute directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
  • In some instances, this position could be the designated lead to manage validation projects.
  • Take a hands-on approach to performing the validation of equipment, utility systems, facilities, processes and/or automation systems and will include tasks such as preparing protocols, analyzing test results, and preparing technical final reports.
  • Define processes and establish procedures for validation activities, as well as support system, process, and SOP improvement efforts currently in place.
  • Investigate and troubleshoot problems, which may occur and propose solutions.
  • Assist in the preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal, client and pre-approval inspections.

  • 3-5 years of experience executing protocols and summarizing results, in support of validation of systems, in a cGMP regulated manufacturing environment is required.
  • In-depth understanding and application of validation principles, concepts, practices, and standards.
  • Proficient in current Good Manufacturing Practices (cGMPs).
  • Extensive working knowledge of manufacturing and laboratory equipment and systems, as well as extensive knowledge of industry practices.
  • Excellent verbal, written and interpersonal communication skills.
  • Must demonstrate investigation and report writing skills.
  • Proficient in MS Office applications.

    Please submit resume for Req. #2169 to . Please visit our website at for more information.

    Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.

    Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.

    Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.

    Please be advised, inquiries or resumes from recruiters will not be accepted.