Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

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Sr. Validation Engineer

Department: Manufacturing
Location: Cambridge, MA

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases.  We are pioneers and explorers, charting a new course. 

If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

As a CMC Validation Engineer you will be the key liaison between Quality, IT, Manufacturing and QC for Validation activities required for life cycle management of GMP systems and equipment.  In this role you will be involved in a range of activities including Continuous Improvement initiatives to mature the validation ecosystem, Commissioning and Qualification and Process Performance Qualification support.  You will be part of a dynamic team focused on transferring upstream and downstream processes for the manufacture of microbiome therapeutics from the laboratory into cGMP clinical manufacturing.  In this role you will have a range of responsibility from planning and leading validation activities to rolling up your sleeves and helping with execution.

What You’ll Do

  • Develop documentation to support commissioning; such as user requirements specifications (URS), commissioning protocols and receipt verifications.
  • Develop and execute protocols, equipment start-ups, field verifications as well as summary report writing
  • Identify and drive Continuous Improvement initiatives to mature the validation ecosystem
  • Develop tools and mechanisms for managing Validation work and reporting progress
  • Manage Commissioning & Qualification contractors by prioritizing C&Q needs according to program and cGMP manufacturing needs; ensure alignment on priorities across CMC functions
  • Provide technical assessments on change controls, deviations, and investigations
  • Work with the Quality team to apply and refine tools for Quality Risk Management

What You’ll Bring

  • Bachelor's degree in Science, Engineering or a related field with 8 years of experience, 5 of which are in an FDA regulated industry
  • Solid experience supporting/driving commissioning and qualification projects related to the biotech and/or pharmaceutical industries
  • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development
  • Strong understanding and ability to apply ASTM E2500 CQV lifecycle model
  • Knowledge of global cGMP requirements and expectations as they pertain to validation
  • Exceptional technical writing, review and analytical skills

You May Also Bring

  • Strong technical acumen in process development, tech transfer, GMP manufacturing
  • Experience with Computerized System Validation
  • Advanced degree

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome.  Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome.  Current candidates span infectious, metabolic, and inflammatory diseases.  For more information, please visit http://serestherapeutics.com/

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