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Senior Quality Validation Engineer

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

About the role

As the owner of all Equipment-related Quality Systems, the Senior Quality Validation Engineer will be responsible for managing a compliant validation program at Vedanta. The individual will lead the implementation of new equipment as well as the requalification of existing equipment per the equipment lifecycle program. Additionally, the the Engineer will support (evaluate, execute, and/or oversee) validation activities for cleaning processes, facilities, utilities, and computer systems.

 

Here’s What You’ll Do:

  • Maintain Validation Master Plan for Vedanta.
  • Maintain the Equipment Lifecycle Program.
  • Manage the validation program including performance of impact assessments, risk assessments for validation, FUSE URS procedures and forms.
  • Review and approve URS and IOQ protocols for FUSE as required.
  • Support cleaning validation activities utilized in current and future processes.
  • Execute area qualification, warehouse mapping, and project timelines for new GMP production area(s).
  • Review and approve Master Equipment FileVs, and CGMP equipment and utilities IOQ protocols and reports.
  • Ownership of all equipment related deviations, CAPAs, and Change Controls
  • Provide validation support for site master file and other regulatory filings.

Requirements:

  • Bachelor’s degree in a scientific discipline, engineering, or a related field.
  • 8-10 years of experience in Validation, Quality Assurance, or a technical support role in the pharmaceutical/biotech industry.
  • Strong communication and technical writing skills. Prior validation experience and authoring validation documents is a must. Experience managing and writing deviations, CAPA, and change controls is preferred.
  • Solid understanding of relevant FDA/EMA/ICH validation requirements.
  • Experience with Veeva Vault QMS or similar software.
  • Strong analytical, organizational, and critical thinking skills.
  • Ability to work in a fast-paced setting and adjust to a changing environment.
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