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Gaithersburg, Maryland, United States
Job reference: R-032116
Posted date: Aug. 07, 2018

MedImmune is the worldwide biologics research and development arm of AstraZeneca.  Our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.

MedImmune is offering a position for an Engineer I / Engineer II within the Engineering and Automation Department – Manufacturing Sciences in Gaithersburg, MD.  The Engineering and Automation Department fulfills the critical role of managing Engineering and Automation functions in support of Clinical Manufacturing at the Gaithersburg Facilities.   The department reports to manufacturing and is accountable for strategic capital project management, automation design and implementation, maintenance of automation systems and administration of infrastructure.  Currently, the department supports four manufacturing areas in the Gaithersburg complex.  As a Process Controls engineer, you’ll play a pivotal part in detailed design, writing PLC code, HMI graphic design, installation and maintenance of automated systems in support of clinical manufacturing operations.  Critical to this effort is collaboration with process development engineers to create new cGMP designs for the development of novel molecules in the MedImmune pipeline.  If you’re inspired by seeking and creating innovative designs to propel manufacturing the cutting edge – join us.    

Major Duties and Responsibilities:

Engineer I:

  • Designs, installs, commissions and validate automation equipment
  • Performs troubleshooting and maintenance on automation equipment
  • Writes PLC code, HMI Code, process control recipes
  • Instructs manufacturing staff on operation of automation equipment
  • Writes cGMP documentation (SOPs, reports, etc.)
  • Reviews specifications, batch records, protocols, and reports for technical accuracy
  • Executes change control in a cGMP environment.
  • Coordinates service contracts and work of outside vendors
  • Coordinates maintenance activities with Facilities
  • Monitors system performance

Engineer II:

In addition to Engineer I skills:

  • Subject Matter Expert (SME) on multiple automation systems
  • Resolves complex automation issues
  • Writes user requirements, specifications, test protocols, and recipes
  • Leads quality/safety investigations
  • Develops technical training plans
  • Develops and manages automation projects
  • Develops and maintains maintenance programs
  • Evaluates new equipment technologies


Engineer I:

  • Creative ability to design and adapt technology to solve unique challenges.
  • Strong problem-solving skills for Infrastructure and Automation systems.
  • Good Engineering Principles
  • Engineering Project Execution
  • Technical Writing
  • Good Documentation Practices (GDP)
  • Commissioning and Qualification (ICQ)
  • Basic Instrumentation and Control
  • Preventive Maintenance
  • Good Automation Manufacturing Practices (GAMP)

Engineer II:

  • GxP principles and standards
  • Cross Functional Project Management
  • Presentation Skills
  • Change management
  • Extensive System Operations (including Automation and Troubleshooting)
  • Validation program
  • Basic PLC Programming and Configuration
  • Basic level OPC
  • FactoryTalk
  • OSI PI Administration
  • S88 Platform


Engineer I:

  • 1-2 years’ experience with Bachelor’s degree in Engineering, Computer Sciences or IT

Engineer II:

  • > 5 years’ experience with Bachelor’s degree in Engineering, Computer Sciences or IT
  • > 3 years’ experience with Master’s degree in Engineering, Computer Sciences

Job Complexity:

  • Works on routine tasks where some judgment is required to make recommendations and resolve problems


Engineer I:

  • Works under moderate supervision
  • Receives instructions, as needed, on routine work and more detailed instructions on new assignments
  • Interacts regularly with functional level peers

Engineer II:

  • Leads Teams
  • Independently performs routine work
  • Designs and plans new projects.
  • Work is reviewed at design and completion for meeting objectives

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Engineer I / II

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  • MedImmune, Gaithersburg, Maryland, United StatesRemove