Senior Engineer, Automation

Novartis • Durham, NC

15d • Onsite

About The Position

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

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 various site automation systems including DCS, BMS, PLC, SCADA, historian, infrastructure, including use of various industrial protocols.
• Experience in development and execution of system level qualification testing including providing guidance on qualification plans in conjunction 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 writing and executing complex change controls.
• 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.
• 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.

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.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees