IT Manufacturing & Lab Systems Engineer

Location
Durham, NC, United States
Posted
Sep 27, 2018
Ref
1069822
Required Education
Bachelors Degree
Position Type
Full time
With its lentiviral-based gene therapy and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. bluebird bio currently has two programs in clinical development - its Lenti-D™ candidate for the treatment of childhood cerebral adrenoleukodystrophy and its LentiGlobin® candidate for the treatment of beta-thalassemia major or severe sickle cell disease. bluebird bio also has a preclinical CAR T cancer immunotherapy program in collaboration with Celgene Corporation, as well as discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies.

IT Manufacturing & Lab Systems Engineer

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. In this role, you will perform GMP IT support functions for bluebird bio Durham, including managing and supporting the onboarding of new lab / manufacturing instruments/equipment and software, working with stakeholders in Manufacturing, Facilities, and Quality Control to ensure smooth operations, quick response times, instrument/equipment and applications uptime and improved scientific/manufacturing productivity overall.

About the role:

Reports into Manager, IT Manufacturing Operations. Perform system administration for laboratory/manufacturing based software and systems. Work closely with functional groups (Manufacturing. Facilities, QC) and corporate / global Lab IT business analysts to identify and deliver computer systems and solutions for laboratory & Manufacturing equipment as requested. Work with global & site IT Manufacturing Operations and End User Services to install, configure, test, maintain, and troubleshoot lab/manufacturing workstation hardware and software. Draft policies and scalable processes to support our growing GMP Manufacturing staff. Escalate issues and requests to IT - management or vendor when appropriate.
  • Perform system administration of both local and enterprise laboratory/manufacturing software and systems; user account management, licensing management, Tier 1-3 incident response and troubleshooting.
  • Administer GxP applications and systems including testing and deployment of OS images, patches and instrument-specific software.
  • Partner with Instrument/Equipment vendors on system requirements, setups and configurations for new systems as well as upgrades to existing systems.
  • Actively respond to incidents and requests for all laboratory instrumentation/manufacturing equipment software and systems.
  • Use the IT helpdesk system to track helpdesk calls and/or escalate issues when necessary.
  • Document relevant information to keep laboratory/manufacturing systems in a maintainable and recoverable state, user accounts, software configurations etc.
  • Participate in GMP validation activities including the development and execution of IQ/OQ/PQ testing.
  • Work with IT Manufacturing Operations to connect laboratory instruments and manufacturing equipment to the process network.
  • Work with IT End User Services in troubleshooting laboratory/manufacturing hardware and software related issues.
  • Work with vendors like Sapio Sciences, Waters, Biomatters, GE, Thermo Fischer, Advance Biosystems and Applied Biosystems to troubleshoot and quickly resolve issues related to critical systems
  • Escalation point for Tier 1 remote staff, ServiceDesk team.


About you:
  • 3-5 years' experience overseeing laboratory systems in a GMP Manufacturing/Laboratory setting is required.
  • Experience supporting/troubleshooting laboratory systems such as bioreactors, flow cytometers, qPCRs highly desirable.
  • Proven working knowledge of GAMP 5, 21 CFR part 11, and Computer System Validation is highly desirable.
  • Experience with administration of LIMS, ELN, and Waters SDMS systems a plus.
  • Experience with ITIL, ServiceNow experience a plus.
  • Excellent communication, customer relations and problem-solving skills a must.
  • Ability to work autonomously on various problems and be willing and able to take on new responsibilities as needed.
  • Ability to execute and follow-through to completion and documentation.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Independently motivated, detail oriented and good problem solving ability.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities. Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.