Senior Automation Engineer (Downstream Buffer

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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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Senior Automation Engineer (Downstream Buffer)

The Senior Automation Engineer (Downstream Buffer) is responsible for providing automation design team leadership and serving as a technical subject matter expert 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.

• Provide design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
• Provide oversight or participation 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 large projects and manage automation contractors as required to complete required work within project timelines.
• Develop project objectives working with user requirements and business plans.
• Determine equipment or system specifications and most cost-effective technology to be implemented.
• Lead 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).
• Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools.
• Maintain procedures to meet GMP requirements, CFR's and internal company policies.
• Participate and/or lead new product implementation processes to ensure smooth transition from process development into GMP manufacturing.
• Drive operational excellence and continuous improvement.
• Partner with Quality to ensure a quality and compliant manufacturing environment.
• Problem solve any 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.
• Deploy, maintain, and upgrade manufacturing applications.
• Perform investigations of non-conformances related to automation systems.
• Analyze and interpret data, and make sound technical recommendations on continuous improvements and non-conformance remediations.
• Execute change controls to update and upgrade automation systems and equipment.

• B.S. degree in Engineering, Computer Science, or related technical field.
• 8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• Excellent oral and written communication skills, including demonstrated technical writing skills.
• Experience programming, troubleshooting, and maintaining site DCS systems, preferably Delta
  
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• 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 development and execution of system level validation testing including providing guidance on qualification plans in conjuction with C&Q department.
• Proven experience applying S88 in an automated environment and development of control system standards aligning with S88 methodology.
• Experience in field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and experience with instrumentation.
• Experience in using industrial communication protocols such as MODBUS, Ethernet IP, etc.
• Experience writing and executing complex change controls.
• Able to develop MS SQL queries and utilize queries to help streamline periodic reviews and other automation tasks.
• In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality processes and end products.
• Experience managing 3rd parties (both in-sourcing and outsourcing).
• Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Provide technical support on all manufacturing issues when driving towards issue…