Senior Automation Engineer (Packaging and Sterlization)

Novartis touches the lives of a tenth of the world’s population. Every role here makes an impact on human life.

About the role

This Senior Automation Engineer (Packaging and Sterilization) provides automation design team leadership and serves as a technical subject matter expert for a Novartis manufacturing facility. Responsibilities include maintaining, troubleshooting, and modifying GMP and non-GMP control systems such as plant-wide DCS, BMS/EMS, MES, and other third-party local control systems.

Responsibilities

• Provide design, configuration, installation, and maintenance of automation software and associated hardware; interact with other teams as necessary.
• Provide oversight or participation on automation aspects of future projects, including integration of third-party equipment to the plant DCS and BMS systems, data concentration, batch reporting, and data retention.
• Prepare scopes of work for large projects and manage automation contractors to complete required work within project timelines.
• Develop project objectives working with user requirements and business plans; determine equipment or system specifications and the most cost-effective technology to be implemented.
• Lead discussions with internal business partners on priorities, timelines, and transparent sharing of information.
• Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS), and Detail Design Specifications (DDS/HDS/SDS).
• Take programs from concept through execution while managing all stages in the process utilizing project management tools.
• Maintain procedures to meet GMP requirements, CFRs, 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 compliant manufacturing environment.
• Problem solve technical issues impacting production; support 24x7 site-based operations including rotating on-call responsibilities.
• Create and update procedures to drive operational efficiency and compliance; implement and revise SOPs to conform with standards and policies.
• Deploy, maintain, and upgrade manufacturing applications.
• Perform investigations of non-conformances related to automation systems; analyze and interpret data to make sound technical recommendations on continuous improvements and non-conformance remediations.
• Execute change controls to update and upgrade automation systems and equipment.

Requirements

• B.S. degree in Engineering, Computer Science, or related technical field.
• 8 years of work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years).
• Excellent oral and written communication skills, including demonstrated technical writing skills.
• Experience programming, troubleshooting, and maintaining site DCS systems, preferably DeltaV.
• Experience programming, troubleshooting, and maintaining site SCADA/HMI systems, preferably Rockwell FactoryTalk View SE.
• Experience programming, troubleshooting, and maintaining site PLC/BMS systems, preferably Allen Bradley CompactLogix/ControlLogix.
• Experience programming, troubleshooting, and maintaining site data historian, preferably OSI PI.
• Experience in development and execution of system-level validation testing, including providing guidance on qualification plans in conjunction with the 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, troubleshooting and start-up of control systems, and instrumentation.
• Experience using industrial communication protocols such as MODBUS, Ethernet IP, etc.
• Experience writing and executing complex change controls.
• Able to develop MS SQL queries and utilize queries to help streamline periodic reviews and other automation tasks.
• In-depth knowledge of FDA regulations, particularly 21 CFR part 11 and GMP systems.
• Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
• Experience managing third parties (both in-sourcing and outsourcing).
• Strong project management skill set with extensive experience in strategic/tactical planning and 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.

Location

Durham, NC (100% onsite)

Pay

Salary range is $124,000 to $186,000 (W-2 only, based on education and experience).

Benefits

• Comprehensive benefits package offered via Novartis.
• Flexible relocation packages available.