Senior Automation Engineer (Packaging and Sterlization)

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

Benefits offered by this job

Benefits Package Offered

Job summary

Novartis in Durham, NC is seeking a Senior Automation Engineer (Packaging and Sterilization) to lead automation design and act as a subject matter expert for the manufacturing facility. You will maintain, troubleshoot, and modify GMP and non-GMP control systems, including plant-wide DCS, BMS/EMS, MES and other local controls.

The role requires strong project management, experience with DeltaV, Rockwell, OSI PI, and SQL queries, plus knowledge of 21 CFR Part 11.

Qualifications

• B.S. degree in Engineering, Computer Science, or related technical field.
• 8 years work experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or 12 years equivalent.
• Excellent oral and written communication skills.
• Experience with DCS, SCADA/HMI, and PLC/BMS systems ( DeltaV, Rockwell, Allen Bradley ).
• Experience with OSI PI data historian.
• Experience in system validation testing and qualification plans with C&Q.
• Knowledge of S88 principles and GMP regulatory expectations.
• Experience with data concentration, batch reporting, and data retention.
• Ability to write and execute change controls.
• Up to 10% travel may be required.

Responsibilities

• Provide design, configuration, installation, and maintenance of automation software and hardware.
• Lead automation aspects of projects including integration of 3rd party equipment to DCS and BMS systems.
• Develop project objectives with user requirements and business plans.
• Establish equipment specifications and standard documentation (URS, FS, DDS).
• Drive continuous improvement and operational excellence.
• Support 24x7 site operations and on-call responsibilities.
• Create and revise SOPs to ensure compliance.

Skills

Automation design

DCS

BMS/EMS

MES

Data analysis

Technical writing

Project management

CFR/21 CFR Part 11

Education

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

Tools

DeltaV

Rockwell FactoryTalk View SE

Allen Bradley 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...

Senior Automation Engineer (Packaging and Sterlization) - Durham, NC (Onsite)

The Senior Automation Engineer (Packaging and Sterlization) 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.
• Up to 10% travel may be required.

Location

Location: Durham, NC (100% Onsite)

Salary

Salary range is $124,000 to 186,000 (W-2 Only - Based on Education and Experience)

Benefits

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].