Automation Engineer III (Upstream/Media)

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.

About the role

This Automation Engineer III (Upstream/Media) position provides automation design team support and serves as a technical subject matter expert on specific systems for a Novartis manufacturing facility. Responsibilities include maintaining, troubleshooting, and modifying GMP and non-GMP control systems such as plant-wide DCS, BMS/EMS, MES, and other 3rd party local control systems.

Responsibilities

• Support design, configuration, installation, and maintenance of automation software and associated hardware, including interacting with other teams as necessary.
• Participate in 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 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, CFRs, 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.

Requirements

• B.S. degree in Engineering, Computer Science, or related technical field.
• 5 years of work experience in pharmaceutical or biopharmaceutical-based GMP manufacturing operations, or equivalent work experience (9 years).
• Experience with large molecule processes, harvest operations, bioreactors, and media.
• Excellent oral and written communication 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 CompactLogix/ControlLogix.
• 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.

Pay

Salary range is $112,800 to $141,000 (W-2 only, based on education and experience).

Benefits

• Comprehensive benefits package offered via Novartis.
• Flexible relocation packages.

Schedule

Location: Durham, NC (100% onsite).