Automation Engineer III (Upstream​/Media)

Please note this is a Direct Hire Position for Novartis.

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

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The Automation Engineer III (Upstream/Media) is responsible for providing automation design team support and serving as a technical subject matter expert on specific systems for a Novartis manufacturing facility. This includes responsibilities for maintaining, troubleshooting, and modifying the GMP and non-GMP control systems. Systems include plant wide DCS, BMS/EMS, MES and other 3rd party local control systems.

• Support design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
• Participate on automation aspects of future projects including integration of 3rd party equipment to the plant DCS and BMS systems, data concentration, batch reporting, and data retention.
• Prepare scopes of work for medium sized automation projects and manage automation contractors as required to complete required work within project timelines.
• Develop project objectives working with user requirements and business plans.
• Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information.
• Establish equipment specifications in standard documentation
  - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
• Maintain procedures to meet GMP requirements, CFR's and internal company policies.
• Participate in new product implementation processes to ensure smooth transition from process development into GMP manufacturing.
• Support operational excellence and continuous improvement.
• Partner with Quality to ensure a quality and compliant manufacturing environment.
• Problem solve technical related issues impacting production.
• Support 24x7 site-based operations including rotating on-call responsibilities.
• Create and update procedures to drive operational efficiency and compliance.
• Implement and revise SOPs to conform with standards and policies.
• Support deployment, maintenance, and upgrading of manufacturing applications.
• Support investigations of non-conformances related to automation systems.
• Execute automation aspects of change controls.

• B.S. degree in Engineering, Computer Science, or related technical field.
• 5 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• Large molecule processes, harvest operations, bio reactor, media.
• Excellent oral and written communication skills.
• Experience programming, troubleshooting, and maintaining site DCS systems, preferably Delta
  
  V.
• Experience programming, troubleshooting, and maintaining site SCADA/HMI systems, preferably Rockwell Factory Talk View SE.
• Experience programming, troubleshooting, and maintaining site PLC/BMS systems, preferably Allen Bradley Compac Logix/Control Logix.
• Experience programming, troubleshooting, and maintaining site data historian, preferably OSI PI.
• Experience in system level validation testing.
• Experience applying S88 in an automated environment.
• Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
• Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc.
• Experience writing and executing change controls.
• Able to develop MS SQL queries.
• Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• Knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality processes and end products.
• Experience working with and leading 3rd parties (both in-sourcing and outsourcing).
• Ability to support contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Provide technical support on all…