Automation Engineer II
Company: Rubius Therapeutics, Inc.
Posted on: February 23, 2021
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
- 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
- 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
- A minimum of 3 years of experience authoring/configuring MES in
a biopharmaceutical/pharmaceutical or related industry.
- Knowledge with troubleshooting Windows operating systems
- Experience with SQL Database, developer DBA is a plus but not
- Experienced with Application Support in a manufacturing
environment a plus.
- Off-hours support coverage via a rotating schedule--to support
- 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 firstname.lastname@example.org account,
Rubius employees or any other company location; Rubius Therapeutics
is not responsible for any fees related to unsolicited
Keywords: Rubius Therapeutics, Inc., Providence , Automation Engineer II, Engineering , Smithfield, Rhode Island
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