Automation Engineer III (Drug Product

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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!

Ready to work with Magnit at Novartis? Please read on...

The Automation Engineer III (Drug Product) 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
• Drug product filling line experience, automated visual inspection, PLCs
• 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 manufacturing issues when driving towards issue resolution.
• Up to 10% travel may be required

Location:

Durham, NC (100% Onsite)

Salary range is $112,800 to 141,000 (W-2 Only - Based on Education and Experience)

• Flexible for Relocation Packages

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status,…