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Senior Process 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

The Role:

The Senior Process Engineer will be responsible for working cross-functionally to design, scale, and implement processes in Vedanta’s manufacturing facilities. This individual is a motivated and experienced process engineer and will focus on operations support, project execution, and tech transfer. The candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. We are searching for enthusiastic, and innovative individuals with a good understanding of late-phase projects from a technical and compliance standpoint. An understanding of phase-appropriate approaches and how to effectively scale operations required. 

Here’s What You’ll Do:

  • Support CQV (Commissioning, Qualification, and Validation) activities for facility and equipment including document review and on-site execution in partnership with validation resources
  • Lead tech transfers within a multiple manufacturing site enterprise in support of high throughput/demand.
  • Participate in day-to-day Tech Transfers including but not limited to manufacturing, manufacturing support, and manufacturing compliance to ensure delivery of departmental commitments to achieve company objectives.
  • Develop standardized documentation including SOP’s, training, validation of equipment, and reports
  • Be a part of project teams in developing project and technology transfer strategy for both clinical and commercial manufacturing campaigns, including process validation and associated regulatory filings.
  • Drive results on multiple complex assignments, in addition to reviewing and guiding the work and performance of vendors/consultants
  • Contribute to decisions based on professional judgement, experience, budget, cGMP regulations, and ethical guidelines of good business practices

Requirements:

  • Engineering degree or equivalent required
  • 5+ years of engineering experience in a biomanufacturing or development environment with 2+ years in a GxP environment preferred
  • Hands-on experience and expertise in microbiome manufacturing processes, such as fermentation, TFF, etc.
  • Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required.
  • Ability to thrive within a fast-moving, dynamic environment. Embraces and drives change where appropriate.

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

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