Automation Engineer III (Upstream/Media)

Novartis; Durham (NC); On-site; USD 113,000 - 141,000; Full time

Benefits offered by this job

Relocation package

Job summary

Novartis seeks an Automation Engineer III (Upstream/Media) for the Durham, NC site. This onsite role supports GMP manufacturing automation design, system integration, and ongoing maintenance of DCS, BMS/EMS, MES, and related control systems.

You will collaborate with cross-functional teams, prepare specifications, participate in change controls, and help drive quality by design, continuous improvement, and supplier coordination. Travel up to 10% may be required.

Qualifications

• B.S. degree in Engineering, Computer Science, or related technical field.
• 5 years work experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or equivalent (9 years).
• Experience with large molecule processes, harvest operations, bioreactor, media.
• Excellent oral and written communication skills.
• Experience with DCS/SCADA/PLC systems and troubleshooting, preferably DeltaV/Rockwell.
• Knowledge of FDA regulations, 21 CFR Part 11, and GMP systems.

Responsibilities

• Support design, configuration, installation, and maintenance of automation software and hardware.
• Participate on automation aspects of projects including 3rd party equipment integration to plant DCS and BMS.
• Prepare scopes of work for automation projects and manage contractors.
• Develop project objectives with user requirements and business plans.
• Maintain procedures to meet GMP CFRs and internal policies; support change controls.

Skills

GMP manufacturing operations

DCS/SCADA/PLC troubleshooting

DeltaV DCS systems

Rockwell FactoryTalk View SE

OSI PI data historian

S88 Automation

FDA 21 CFR Part 11 knowledge

MS SQL queries

System validation testing

Third-party coordination

Education

B.S. in Engineering, Computer Science, or related technical field

Tools

DeltaV

FactoryTalk View SE

CompactLogix/ControlLogix

OSI PI

MS SQL

Job description

Please note this is a Direct Hire Position for Novartis.

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!

Ready to work with Magnit at Novartis? Please read on...

Automation Engineer III (Upstream/Media) - Durham, NC (Onsite)

The Automation Engineer III (Upstream/Media) is responsible for providing automation design team support and serving as a technical subject matter expert on specific systems 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

• Support design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
• Participate 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 medium sized automation projects and manage automation contractors as required 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, CFR's 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 work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• Large molecule processes, harvest operations, bio reactor, 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 CompacLogix/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.

Location

Durham, NC (100% Onsite)

Salary

Salary range is $112,800 to 141,000 (W-2 Only - Based on Education and Experience)

Benefits Package Offered (via Novartis)

• Flexible for Relocation Packages

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?

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.