Senior Engineer, Automation

Role 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. Location: Durham, NC; on-site role.

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 responsibilities.
• Support investigations of non-conformances related to automation systems.
• Other related duties as assigned.

Qualifications

• Required: B.S. degree in Engineering, Computer Science, or related technical field.
• Required: 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: Excellent oral and written communication skills, including demonstrated technical writing skills.
• Required: Experience programming, troubleshooting, and maintaining various site automation systems including DCS, BMS, PLC, SCADA, historian, infrastructure, including use of various industrial protocols.
• Required: Experience in development and execution of system level qualification testing including providing guidance on qualification plans in conjunction with C&Q department.
• Required: Proven experience applying S88 in an automated environment and development of control system standards aligning with S88 methodology.
• Required: Experience in field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and experience with instrumentation.
• Required: Experience writing and executing complex change controls.
• Required: In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• Required: Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.
• Required: Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Required: Provide technical support on all manufacturing issues when driving towards issue resolution.
• Required: Up to 10% travel may be required.

Education

• BS in Engineering, Computer Science, or related technical field.

Additional Requirements

• Up to 10% travel may be required.