Senior DeltaV Engineer

Novartis touches the lives of a tenth of the world’s population. Every role here makes an impact on human life.

About the role

This Senior DeltaV Engineer position provides automation design team leadership and serves as a technical subject matter expert 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 third-party local control systems.

Responsibilities

• Provide design, configuration, installation, and maintenance of automation software and associated hardware; interact with other teams as necessary.
• Oversee or participate in automation aspects of future projects, including integration of third-party equipment to plant DCS and BMS systems, data concentration, batch reporting, and data retention.
• Prepare scopes of work for large projects and manage automation contractors to complete work within project timelines.
• Develop project objectives based on user requirements and business plans; determine equipment or system specifications and cost-effective technology.
• Lead discussions with internal business partners on priorities, timelines, and transparent information sharing.
• Establish equipment specifications in standard documentation: User Requirements (URS), Functional Specification (FS), and Detail Design Specifications (DDS/HDS/SDS).
• Take programs from concept through execution while managing all stages using project management tools.
• Maintain procedures to meet GMP requirements, CFRs, 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 compliant manufacturing environment.
• Problem-solve technical 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; make sound technical recommendations on continuous improvements and non-conformance remediations.
• Execute change controls to update and upgrade automation systems and equipment.

Requirements

• Bachelor's Degree.
• 8 years of work experience 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 CompactLogix/ControlLogix.
• Experience programming, troubleshooting, and maintaining site data historian, preferably OSI PI.
• Experience in development and execution of system-level validation testing, including guidance on qualification plans 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, panel design, troubleshooting, start-up of control systems, and instrumentation.
• Experience 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 them to 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.
• Experience managing third parties (both in-sourcing and outsourcing).
• Strong project management skill set with extensive experience in strategic/tactical planning and 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 toward issue resolution.
• Up to 10% travel may be required.

Pay

Salary range is $124K–$186K (W2 – based on education and experience).

Benefits

• Benefits package offered via Novartis.
• Flexible relocation packages.

Schedule

Location: Durham, NC (100% onsite).