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 (DeltaV), BMS (Rockwell SCADA) and 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.
• Other related duties as assigned.

Planning Timelines Operations Automation Innovation Outsourcing Communication Investigation Change Control Pharmaceuticals FDA Regulations Team Leadership Control Systems Computer Science Technical Writing Electrical Wiring Biopharmaceuticals Project Management Automation Systems Validation Testing Systems Engineering Process Development Statistical Analysis Contingency Planning Rockwell FactoryTalk Design Specifications Six Sigma Methodology Microsoft SQL Servers Operational Historian Operational Excellence Operational Efficiency New Product Development Quality By Design (QbD) Functional Specification Manufacturing Operations Human Machine Interfaces Communications Protocols Technical Subject Matter Building Management System User Requirements Documents Distributed Control Systems Code Of Federal Regulations Good Manufacturing Practices Open Systems Interconnection Programmable Logic Controllers Troubleshooting (Problem Solving) DeltaV Distributed Control System Manufacturing Execution System (MES), * 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 DeltaV.
• Experience programming, troubleshooting, and maintaining site SCADA/HMI systems, preferably Rockwell FactoryTalk View SE.
• Experience programming, troubleshooting, and maintaining site PLC/BMS systems, preferably Allen Bradley CompacLogix/ControlLogix.
• 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 OpsTrakker.
• 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, 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 resolution.
• Up to 10% travel may be required., Leadership Automation Innovation Reliability Ladder Logic ControlLogix Communication Team Oriented Commissioning Systems Design Logic Diagrams Detail Oriented Microsoft Excel Problem Solving Control Systems Instrumentation Microsoft Office Technical Design Electrical Wiring Quality Monitoring Development Testing Systems Integration Mechanical Drawings Electrical Equipment Technical Engineering Industrial Automation Artificial Intelligence Human Machine Interfaces Communications Protocols Engineering Design Process Verbal Communication Skills Personal Protective Equipment Programmable Logic Controllers Continuous Improvement Process Troubleshooting (Problem Solving) Continuous Emissions Monitoring Systems Programmable Logic Controllers Programming +0 Isp Tech TEKsystems

Raleigh, NC*Remote

Operations Leadership Positivity Multitasking Detail Oriented Professionalism Problem Solving Customer Service Business Metrics Technical Issues Operating Systems Help Desk Support Quality Assurance Account Management Performance Metric Business Valuation Software Installation Full Stack Development Artificial Intelligence Business Transformation Hardware Troubleshooting Customer Complaint Resolution Troubleshooting (Problem Solving) +0

Google IT Automation with Python

Google IT Support BIM/VDC Specialist (Remote) Actalent

Raleigh, NC*Hybrid

HVAC AutoCAD Plumbing Autodesk Visionary Leadership Innovation Coordinating Shop Drawing Communication Collaboration Accountability Autodesk Revit Microsoft Excel Problem Solving Microsoft Office Plumbing Systems Project Schedules Technical Drawing Project Management Organizational Skills Collaborative Software Artificial Intelligence Engineering Design Process Interpersonal Communications Building Information Modeling

• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you., The salary for this position is expected to range between $108,500 and $201,500 annually

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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Why Novartis: 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? https://www.novartis.com/about/strategy/people-and-culture