Senior Automation Engineer

Magnit Global; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Novartis Durham site seeks a Senior Automation Engineer (Downstream Buffer) to lead the automation design team and serve as SME for GMP and non-GMP control systems, including DCS, BMS/EMS, MES and related local systems. You will oversee installation, commissioning, troubleshooting, and ongoing improvements to keep manufacturing compliant and efficient.

The role requires a B.S. in engineering or related field, 8+ years in GMP pharma, strong communication, with DeltaV, Rockwell, OSI PI, and S88

Qualifications

• B.S. degree in Engineering, Computer Science, or related technical field.
• 8+ years in pharmaceutical/biopharmaceutical GMP manufacturing (or 12 years if applicable).
• Strong communication skills and technical writing experience.
• Experience with DCS, SCADA/HMI, PLC/BMS, and data historians.

Responsibilities

• Lead design, configuration, installation, and maintenance of automation software and hardware.
• Oversee automation aspects of projects and integration of third-party equipment.
• Develop scopes of work and manage automation contractors to schedule.
• Lead validation planning and support CQ/QA activities.
• Drive continuous improvement and operational excellence.

Skills

DeltaV experience

Rockwell FactoryTalk

OSI PI

S88 experience

Project leadership

Data analysis

GMP compliance

Education

B.S. in Engineering or related field

Tools

DeltaV

Rockwell FactoryTalk View SE

Allen Bradley PLCs

OSI PI

MODBUS/Ethernet IP

Job description

The Senior Automation Engineer (Downstream Buffer) is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis manufacturing facility. This includes responsibilities for maintaining, troubleshooting, and modifying the GMP and non-GMP control systems. Systems include plant wide DCS, BMS/EMS, MES and other 3rd party local control systems.

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.

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 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 in development and execution of system level validation testing including providing guidance on qualification plans in conjuction 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.