open positions

Senior Validation Engineer

Location: Somerville, Massachusetts, 02143, United States
Full-time

About Finch  

Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.  

With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively. 

 

Position Summary 

Finch Therapeutics is looking for a Mid/Senior Level Validation Engineer who will be primarily responsible for executing qualification and validation activities to drive overall quality and compliance at Finch Therapeutics. The ideal candidate must possess excellent background on equipment, cleaning, and instrument validation. The candidate must work independently as well as in a cross-functional team and has ability to multitask.

 

Responsibilities 

  • Providing support to Equipment, Cleaning, Instrumentation, and Computerized System validation
  • Generate/Revise and Execute Commissioning, Installation, Operational, and Performance Qualification Protocols in conjunction with engineering, manufacturing, and quality personnel.
  • Performs qualification of facilities, utilities, manufacturing, lab equipment, computer system, and packaging.
  • Generate validation summary reports for various life science qualification activities.
  • Participate in discrepancy/deviation investigations and corrective/preventive actions.
  • Provide technical assessments on change controls, deviations, and investigations.
  • Contribute to the successful completion of project milestones and crucial technical tasks.
  • Act as a technical contact/SME for validation contractors.
  • Develop and revise new or existing validation procedures/protocols, as needed.

 

Qualifications  

  • BS in Engineering, Pharmaceutical Manufacturing, or related field.  
  • 5+ years of experience in pharmaceutical industry.
  • Validation experience on lyophilizer, autoclave, part washer, biosafety cabinet, freezer, refrigerator, incubator is preferred.
  • Familiarity with validation tools and processes, including use of Eval-Pro.
  • Experience writing/executing qualification protocols (IQ/OQ/PQ), and commissioning test plans (CTP).
  • Experience with Process development and validation.
  • Experience with Cleaning development and validation.
  • Experience with Computerized System validation (CSV) is plus.
  • Ability to work independently; demonstrated ability to interact well with cross-functional departments.
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
  • Excellent communication skills
  • Knowledge on automation systems.
  • Familiarity with FDA and EU regulations for pharmaceuticals and medical devices.

 

More About Finch 

Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients. 

  • Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
  • We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team. 

*Only facility-dependent employees are working on-site in Somerville until further notice. 

 

Equal Opportunity Employer 

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool.  All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.