Novartis
Pharmaceutical
SeniorEngineer,Automation
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Engineer, Automation at Novartis. Skills: Automation, GMP manufacturing, Project management. Ensure automation aspects of new equipment are designed. Meet Novartis standards for equipment”
What You'll Achieve.
Ensure smooth transition from process development into GMP manufacturing
Industry & Context.
Troubleshooting; Root cause analysis; Issue resolution
On-site role, Rotating on-call responsibilities, Up to 10% travel
What They're Looking For.
Must Have
B.S. degree in Engineering, Computer Science, or related technical field, 8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, Experience programming, troubleshooting, and maintaining various site automation systems, Experience in development and execution of system level qualification testing, Proven experience applying S88 in an automated environment, Experience in field wiring practices and panel design, Experience with troubleshooting and start-up of control systems, Experience with instrumentation, Experience writing and executing complex change controls, In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems, project management skill set with extensive experience in strategic / tactical planning, Ability to prepare contingency plans and logically work through complex issues
Nice to Have
12 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, Providing guidance on qualification plans in conjunction with C&Q department, Development of control system standards aligning with S88 methodology, Demonstrated ability to perform long-term project planning
What You'll Do.
Ensure automation aspects of new equipment are designed
Meet Novartis standards for equipment
Commission and qualify new equipment
Provide oversight for automation aspects of projects
Integrate 3rd party equipment to plant systems
Provide design of automation software
Provide configuration of automation software
Provide installation of automation software
Maintain automation software
Prepare scopes of work for large projects
Manage automation contractors
Lead discussions with internal business partners
Develop lifecycle documentation
Review lifecycle documentation
Approve lifecycle documentation
Develop procedures to meet GMP requirements
Maintain procedures to meet GMP requirements
Participate in new product implementation processes
Lead new product implementation processes
Drive operational excellence
Drive continuous improvement
Ensure compliant manufacturing environment
Participate in regulatory audits
Solve technical related issues impacting production
Support 24x7 site-based operations
Support investigations of non-conformances related to automation systems
Perform other related duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional teams; Internal business partners; Quality department; C&Q department
Communication Scope
Oral communication; Written communication; Technical writing
Process & Methodology
Strategic planning, Tactical planning, Long-term project planning, Project commissioning, Project engineering, Project execution
Full Job Description
**Job Description Summary** 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 Aseptic Drug Product facility. **Job Description** **Location:** This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. **Key Responsibilities:** * Ensure automation aspects of new equipment are appropriately designed, meet Novartis standards and are appropriately commissioned and qualified. * Provide oversight for automation aspects of projects including integration of 3rd party equipment to other standard plant systems, e.g., DCS, BMS, Historian, Infrastructure. * Provide design, configuration, installation, and maintenance of automation software and associated hardware for existing equipment and processes. * Prepare scopes of work for large projects, lead small teams and manage automation contractors as required to complete required work within project timelines. * Lead discussions with internal business partners on priorities, timelines and transparent sharing of information. * Develop, review and approve lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). * Develop and 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 including participation in regulatory audits as an automation SME. * Solve technical related issues impacting production. * Support 24x7 site-based operations including rotating on-call responsibilit
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