Sr. Automation Engineer Drug Product
Novartis - Durham, NC
Hiring: Sr. Automation Engineer Drug Product Company: Novartis Location: Durham, NC Job Posted Time: 2026-09-10 10:21:07 Employment Type: On-site Target Skills & Keywords : C About the job Experience: •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. Required Skills: •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. •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). Qualifications: •B.S. degree in Engineering, Computer Science, or related technical field. •Excellent oral and written communication skills, including demonstrated technical writing skills. •Proven experience applying S88 in an automated environment and development of control system standards aligning with S88 methodology. •In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. •Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning. •Demonstrated capacity 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. •Novartis Compensation And Benefit Summary •The salary for this position is expected to range between $108,500 and $201,500 annually. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!