Senior DeltaV Engineer, Drug Product

Location:

This position will be located in Durham, NC and will be an On‑Site role.

• 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.

• 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.

• The salary for this position is expected to range between $108,500 and $201,500 annually.
• The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically.
• Novartis may change the published salary range based on company and market factors.
• Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
• 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.