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Quality Validation Engineer II

Rubius Therapeutics
SMITHFIELD, Rhode Island, United States
30+ days ago

Description

Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. Our proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our therapies can potentially be used to kill tumors in cancer and to regulate the immune system for the treatment of autoimmune diseases. We are currently enrolling patients in a Phase 1/2 clinical trial of RTX-240 in patients with relapsed/refractory or locally advanced solid tumors. In addition, RTX-240 is being evaluated in a second Phase 1 arm of the clinical trial for the treatment of patients with relapsed/refractory acute myeloid leukemia, and our IND has been cleared by the U.S. FDA for RTX-321 for the treatment of human papillomavirus 16-positive cancers.
 
We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are headquartered in Cambridge, MA, and our manufacturing facility in Smithfield, RI was named 2020 Top 5 Best Places to Work in Rhode Island among medium-sized companies by Providence Business News. We are currently expanding across all functions within the organization. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com, or follow us on Twitter and LinkedIn or like us on Facebook.

Summary

Rubius is seeking to add a new “Ruby” to the Quality Organization as a Quality Validation Engineer II. Our team members work collaboratively and are motivated self-starters who deliver exceptional work.  Do you thrive on working on the cutting edge?  Working with innovators in the early stages of ideas, products, or platforms?  Do you want to transform patient lives? You are responsible for the Quality oversight of qualification and validation activities at the Rubius Manufacturing Facility in Smithfield, RI in accordance with company policies, site procedures, industry guidance and health authority regulations.  You will provide Quality input to Quality Control, IT and Facilities/Engineering and ongoing support of quality events, CAPA, and change controls related to analytical methodologies, laboratory equipment, qualification, validation, automation, utilities, and aseptic processing.  You will utilize your experience to review and approve qualification/validation documentation developed to support the delivery of key capital projects, provide quality input to facilitate the ongoing lifecycle management defined by the commissioning, qualification, and validation programs.  Key to success is the ability to partner cross-functionally and cross-site while maintaining high standards of compliance.  You love to communicate, are obsessive about the details, and know how to have fun on this journey. 

Responsibilities
  • Serve as a QA liaison with the Quality Control, Analytical Development, Validation, Facilities/Engineering, and Manufacturing, organizations to support company goals and continuous improvement initiatives.
  • Serve as a QA resource supporting the change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to analytical methodologies and associated equipment/instruments.
  • Provide QA support, including review and approval, for Quality Events and investigations related to protocol discrepancies, unexpected results and equipment/instrument failures ensuring events are contained, risks mitigated, impacts to equipment, product and processes are adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions implemented.
  • Support electronic system initiatives such as Laboratory Information Management System (LIMS) and Computerized Maintenance Management System (CMMS) for preventative maintenance/calibration programs including validation activities, review of electronic data, performing queries and generating reports.
  • Assist in the review and approval process resulting in timely and technically appropriate input of cGMP analytical operations including the review/approval of process and equipment lifecycle documentation (Validation Protocols/Reports, Design Review/Qualification, URS, FRS, DRS, SAT/FAT, IQ/OQ/PQ, PPQ).
  • Provide QA support of the Preventative Maintenance/ Calibration Program, including development and/ or review and approval of completed calibrations and maintenance tasks. Ensure content and frequency of calibration and preventative maintenance are suitable for the intended application.
  • May support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis.
  • Provide support and assist with risk assessments for computer systems to assure compliance with applicable regulations and guidance, e.g. 21 CFR Part 11, ISPE (GAMP 5)
  • Lead the development and implementation training initiatives as applicable to the QA Validation group and create department related training materials and other supplemental training content as required.   
  • Conduct training needs assessments to ensure training is provided to the proper personnel per business needs and compliance requirements.
  • Author and/or review new and revised GMP documentation.


Requirements

  • BS/BA degree in Engineering, Chemistry, Biology or related field.
  • 6 years of GMP related experience in biopharmaceutical / pharmaceutical or related industry with 2+ years direct Analytical Method Validation experience preferred. A combination of education and experience will be considered.
  • Experience with MS Office applications (such as Word, Excel, PowerPoint) preferred.
  • Experience with aseptic processing and cell therapy products is a plus.
  • Experience in U.S. required, experience in EU and APAC regions is a plus.

Job Information

  • Job ID: 59249685
  • Location:
    SMITHFIELD, Rhode Island, United States
  • Company Name: Rubius Therapeutics
  • Position Title: Quality Validation Engineer II
  • Job Function: Accounting,
    Biotherapeutics
  • Job Type: Full-Time

Please refer to the company's website or job descriptions to learn more about them.

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