Senior Process Engineer

Rubius Therapeutics, Inc. Smithfield , RI 02917

Posted 2 weeks ago

Rubius Therapeutics is a clinical-stage biopharmaceutical company that is generating red blood cells and engineering them into an entirely new class of allogeneic, off-the-shelf cellular medicines. Our Red Cell Therapeutics can potentially be used to replace missing enzymes for patients living with rare enzyme deficiencies, kill tumors in cancer and regulate the immune system for the treatment of autoimmune diseases. We expect to begin enrolling patients in our first clinical trial during the second quarter of 2019, which is evaluating RTX-134 for the treatment of phenylketonuria, an inherited metabolic disorder. Additionally, we plan to file our first oncology IND for RTX-240 for the treatment of solid tumors by early 2020. In total, we plan to file four to five INDs during 2019 and 2020.

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 based in Cambridge, MA and currently expanding across all functions within the organization. Having completed our initial public offering in July 2018, (Nasdaq: RUBY), we are well capitalized to execute our vision of creating life-changing cellular medicines. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn.

Summary

We are looking for a Sr. Process Engineer to join our Smithfield, RI Engineering Organization to establish and implement process engineering standards related to the specification, procurement, commissioning, and qualification of process equipment. The incumbent is expected to act as an interdepartmental and single point of contact throughout the process equipment engineering lifecycle. Multi-tasking, independent problem-solving skills and the ability to lead cross functional investigative teams to define user and requirements will be key to success in this position. Also, key to the success of this position is experience with single-use equipment as well as knowledge of multiple disciplines including process engineering, automation, instrumentation, and validation. The Sr. Process Engineer will lead departmental or cross-functional teams and activities to ensure completion of projects while adhering to budget, scope and schedule requirements.

Responsibilities

  • Lead cross-functional effort to define and author user and functional requirements, purchase specifications, process flow diagrams, instrument specifications, and other engineering lifecycle documentation.

  • Lead cross-functional teams to commission, qualify, and troubleshoot process equipment. Perform investigations of process deviations and out-of-specification results, related to process equipment, to determine root cause.

  • Identify appropriate CAPA to prevent reoccurrence of issues related to the performance or functioning of process equipment.

  • Partners with peers in manufacturing, engineering, validation, logistics and QC to specify process equipment in accordance with Rubius procedures and Good Engineering Practice.

  • Serve as a Subject Matter Expert (SME) in regulatory inspections for process equipment engineering lifecycle and deviations related to process equipment.

  • Ensures that appropriate site SOP's and documentation are in place to support Rubius adherence to good engineering practice with respect to process equipment.

  • Prepares metrics and summaries to effectively communicate status and recommendations to Senior Management.

  • Support and service as mentor to lower level process engineers.

  • Interacts professionally with company management, internal departments and other sites to effectively implement and maintain standards and procedures for the lifecycle of process equipment.

Education & Experience

  • Bachelor's degree in Engineering (Chemical or Mechanical) with 6 to 8 years' experience in biopharmaceutical/pharmaceutical or related industry.

  • Experience with a cell therapy product and single-use technology is preferred

  • Thorough knowledge of cGMPs, EU/ICH and global regulatory requirements related to equipment lifecycle.

  • Thorough knowledge of ASME-BPE and single-use technology.

  • Previous experience in early phase clinical operations is desired. Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals.

  • Team-oriented approach to project management and problem resolution.

EEO Statement: Rubius Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Recruitment & staffing agencies: Rubius Therapeutics does not accept agency resumes unless contacted directly by internal Rubius Talent Acquisition. Please do not forward resumes to our careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.


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