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.

About the Role

Location:

* 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.

Key Responsibilities:

* 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.

Essential Requirements:

* 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 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,…