Senior/Level III Engineer, Automation

Novartis Farmacéutica; Durham (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Automation Engineer to lead automation design and provide technical expertise for a cutting-edge gene therapy manufacturing facility. In this pivotal role, you will be responsible for maintaining and troubleshooting complex control systems, including DCS and SCADA. You will collaborate with various teams to ensure project timelines are met and that all systems comply with GMP standards. This is an exciting opportunity to make a significant impact in the biopharmaceutical sector, where your skills will contribute to the advancement of innovative therapies. If you are passionate about automation and eager to work in a dynamic environment, this role is for you.

Qualifications

• 8+ years of experience in GMP manufacturing operations.
• Strong programming and troubleshooting skills in DCS and SCADA systems.

Responsibilities

• Lead automation design and maintenance for GMP control systems.
• Oversee integration of 3rd party equipment into plant systems.

Skills

Automation Design Leadership

Technical Subject Matter Expertise

Troubleshooting Control Systems

Project Management

Technical Writing

Communication Skills

Education

B.S. degree in Engineering

B.S. degree in Computer Science

Tools

DeltaV DCS

Rockwell SCADA

Allen Bradley CompacLogix/ControlLogix

OSI PI Data Historian

Job description

Position: Senior/Level III Engineer, Automation

This position will be located at Durham, NC and will not have the ability to be located remotely.

The Senior Automation Engineer reports to the AD Process Automation and is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis gene therapy manufacturing facility. This includes responsibilities for maintaining, troubleshooting, and modifying the GMP and non-GMP control systems. Systems include plant wide DCS (DeltaV), BMS (Rockwell SCADA) and 3rd party local control systems.

Key Responsibilities:

1. Provide design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
2. 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.
3. Prepare scopes of work for large projects and manage automation contractors as required to complete required work within project timelines.
4. Develop project objectives working with user requirements and business plans.
5. Determine equipment or system specifications and most cost-effective technology to be implemented.
6. Lead discussions with internal business partners on priorities, timelines and transparent sharing of information.
7. Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
8. Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools.
9. Maintain procedures to meet GMP requirements, CFR’s and internal company policies.
10. Participate and/or lead new product implementation processes to ensure smooth transition from process development into GMP manufacturing.

About the Role

The level of the position will be commensurate with education, applicable experience, competency and independence.

• 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 system level validation testing.