Title: Senior Process Engineer
Location: Cambridge, MA
Reports to: Associate Director, Technical Operations
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
- 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.
Why join Vedanta Biosciences
Vedanta is pioneering the development of a new class of therapies 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. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology.
We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.
We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia
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.