Automation Engineer II

Company: Rubius Therapeutics, Inc.
Location: Smithfield
Posted on: February 23, 2021

Job 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 We are seeking an Automation Engineer II with a primary focus to serve as a member for our Syncade Manufacturing Execution System team. Secondary responsibilities will include supporting colleagues with other automation systems such as Filter Integrity Testers (FIT's), DeltaV, Pi, VI-cell, and active directory. The successful candidate will have experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise installing, deploying, supporting, and troubleshooting Manufacturing Execution System (MES).-- Responsibilities

• Perform MES application administration for Sandbox, Development, Test and Production environments.
• Configure Master Data as directed by Manufacturing and MS&T such as material master, BOM configurations and Electronic Batch Record (eBR)/electronic Logbook (eLog) creation.
• Ability to write and maintain GMP system documents such as Standard Operator Procedures (SOP's), Installation/Operational Qualification (IOQ's), Functional Specifications (FS's), and Configuration Specifications (CS's).
• Perform MES peripherals setup and troubleshooting such as scanners, printers, and scales.
• Strong troubleshooting skills on all aspects of MES such as eBR use, remote connections, user accounts, material transactions and network connections.
• Working knowledge of current Good Manufacturing Practice (cGMP) and Good Automation Manufacturing Practices (GAMP).
• Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards.
• Ability to convert business requirements in functional electronic workflows.
• This position interacts with external organizations, consultants and vendors as required in the successful accomplishment of project assignments.
• Participate in validation activities in combination with Validation and Quality departments.
• Ability and desire to learn existing automation systems to provide redundancy and backup to the automation team.
• Demonstrates a 'get things done' attitude and inspires others to perform at a high level. Qualifications & Education
  • Bachelor's degree in an engineering, computer science or other technical degree.
  • A minimum of 3 years of experience authoring/configuring MES in a biopharmaceutical/pharmaceutical or related industry.
  • Knowledge with troubleshooting Windows operating systems desired.
  • Experience with SQL Database, developer DBA is a plus but not required.
  • Experienced with Application Support in a manufacturing environment a plus.
  • Off-hours support coverage via a rotating schedule--to support Manufacturing.
  • Experience with Emerson Syncade MES is preferred.-- 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.

Keywords: Rubius Therapeutics, Inc., Providence , Automation Engineer II, Engineering , Smithfield, Rhode Island