Senior Quality Engineer
Location: Somerville, Massachusetts, 02143, United States
Finch is a clinical-stage company developing novel microbiome drugs to serve patients with serious unmet medical needs. Our machine learning-based platform mines molecular data collected from human interventional studies to identify the microbial communities driving positive patient outcomes in different disease areas. By developing drugs from microbial communities that have already demonstrated therapeutic effects in humans, we are pioneering a new approach to drug discovery and rapidly transforming the promise of the microbiome into a reality for patients.
Our lead therapeutic candidate, CP101, is initially targeting the prevention of recurrent C. difficile infection (CDI). CP101 recently met its primary endpoint in a large placebo-controlled trial in recurrent CDI, providing the first positive pivotal data for an oral microbiome drug. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious GI symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease.
The Senior Quality Engineer will be responsible for quality engineering related activities in support of the construction, commissioning, and qualification of a cGMP commercial manufacturing facilities, process tech transfer, process validation, cleaning validation. This role will also lead in conducting risk assessment, mitigation and management and support all Quality related activities, such as Change Controls, CAPAs, Engineering Change Management, and Deviations. The Senior Quality Engineer will lead in QA Projects as part of continuous improvement efforts and provide guidance to other functional areas to assure awareness of and compliance with engineering, qualification and validation requirements.
The Senior Quality Engineer will be a champion for quality principles and practices, risk management, and compliance for the organization.
Responsibilities / Duties
- Serve as the Quality Lead and review qualifications, validations, and other technical studies for content, statistical and sampling rationale, unintended impact, clarity, and ensure compliance with established standards and procedures for: Facility, equipment and utility (FEU) systems, computer systems, process validation, cleaning validation, and technical studies
- Lead the adherence to site Validation Master Plans, review and approve qualification/validation protocols, final reports and analyze resultant data
- Review and approve the creation and revision of SOPs, User Requirements Specifications (URS), Master Batch Records (MBRs), technical protocols and reports
- Review and disposition of non-conformances, assuring appropriate decisions, testing, data and records are completed
- Review, approval and implementation of change control records
- Assist process validation studies to develop a thorough understanding of operating and performance parameters
- Support process transfer from early and late stage process development for clinical and commercial manufacturing
- Cross functionally collaborate with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed
- Provide guidance to the teams to assure awareness of validation requirements and compliance.
- Ensure validation support structure and document handling systems are established and maintained
- Participate and serve as Quality Lead in system, process, product, and program improvement teams
- Prepare and participate in regulatory agency audits as well as internal audits
- Perform other duties as applicable
- Bachelor’s degree in Engineering, Science or related technical field
- 6+ years of quality, process development and/or manufacturing experience in biotech or pharmaceutical industry, with at least 3 years in Validation, i.e., Process Validation, Cleaning Validation, Facility/Equipment/Utility (FEU) commissioning and qualification
- Proven knowledge of GAMP, ASTM E2500, GEP, and other engineering standards and practices
- Proven knowledge of FDA regulations and ICH Guidelines, e.g., 21 CFR Parts 11, 210 and 211, 600, ICH Q6, Q7, Q8, Q9, Q10, and etc.
- Proven knowledge and experience of risk-based approaches to process development and validation
- Deep and broad understanding of quality processes including change control, process control, risk assessment and management, and root cause analysis.
- Experience developing and executing tech transfer into cGMP commercial manufacturing facility
- Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
- Knowledge of data management tools and statistical process controls is preferred
- Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
- Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
- Drive change, efficiency, and strong cross-functional relationships
- Strong problem solving, trouble shooting, and analytical skills
- Strong knowledge of quality engineering
- Ability to constructively progress to outcomes despite uncertainty or ambiguity
- Ability to drive continuous improvements
- Ability to influence and demonstrate strong command to achieve outcomes
- Ability and desire to work in a fast-paced and dynamic environment
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 Blue Cross Blue Shield 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, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox. 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.
*Though only facility-dependent employees are currently working onsite in Somerville, Ma, we all plan to return to the office when it’s safe to do so.
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.