Senior Automation Engineer

Summary

The Senior Automation Engineer reports to the Site ITOT Head and is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis gene therapy manufacturing facility. This includes responsibilities for maintaining, troubleshooting, and modifying the GMP and non‑GMP control systems. Systems include plant wide DCS (Delta

V), BMS (Rockwell SCADA) and 3rd party local control systems.

• This position will be located in Durham, NC and will be an onsite role.
• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

• 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.
• Other related duties as assigned.

• 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
  
  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 configuring and maintaining Statistical Analysis packages, preferably Statistica.
• Experience configuring and maintaining MES, preferably Ops Trakker.
• Experience in development and execution of system level validation testing including providing guidance on qualification plans in conjunction with C&Q department.
• Proven experience applying S88 in an automated environment and development of control system standard aligning with S88 methodology.
• Experience in field wiring practices and panel design, experience with troubleshooting…