Senior DeltaV Engineer

Novartis; Durham (NC); On-site; USD 124,000 - 186,000; Full time

Benefits offered by this job

Relocation package

Job summary

Novartis is seeking a Senior DeltaV Engineer to lead automation design, configuration, and maintenance for GMP manufacturing facilities. The role includes oversight of DCS/BMS/EMS, MES, and third-party integrations, with a focus on data integrity and batch reporting.

You will develop URS/FS/DDS, manage project timelines, and drive continuous improvement across systems. The ideal candidate brings 8+ years in pharma GMP environments, strong technical writing, and hands-on experience with DeltaV,

Qualifications

• Bachelor's degree required.
• 8+ years in pharma/biopharma GMP environments.
• Strong communication, technical writing, and collaboration skills.
• Experience with DeltaV, Rockwell FactoryTalk, and PLC/BMS systems.
• Familiarity with data historians, OSI PI, and SQL queries.
• Knowledge of S88, FDA 21 CFR Part 11, and quality by design.

Responsibilities

• Lead automation design and provide SME guidance across projects.
• Oversee automation contractors and manage scopes for large initiatives.
• Develop URS/FS/DDS/HDS/SDS and ensure GMP compliance.
• Lead change controls and document procedures for efficiency and compliance.
• Support 24x7 site operations and on-call rotations.
• Partner with Quality to ensure manufacturing excellence.

Skills

Project management

Technical writing

Communication skills

Problem-solving

Quality by Design

Six Sigma

FDA 21 CFR Part 11

S88 instrumentation

Vendor management

Regulatory compliance

Education

Bachelor's Degree

Tools

DeltaV

Rockwell FactoryTalk View SE

Allen-Bradley PLCs

OSI PI

MODBUS

Ethernet/IP

MS SQL

DCS/BMS/EMS

GxP validation tooling

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...

Senior DeltaV Engineer

The Senior DeltaV Engineer 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.

Key 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.

Essential Requirements:

• Bachelor's Degree
• 8 years 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 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.
• Up to 10% travel may be required.

Location:

Durham, NC (100% Onsite)

Salary range is $124K-$186K. (W2 - 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.

Accommodation:

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [e-mail].