Senior Automation Engineer in San Diego, CA

Duties:

• The Senior Engineer, Automation, provides technical leadership to the automation team at our gene therapy technical research and development facility.
• This role will be responsible for driving automation solutions to integrate process and analytical equipment with the operational technology infrastructure by working with the equipment manufacturers.
• This role will work in liaison with development teams to meet the requirements and timelines for new projects and programs and support transfer of technologies to the manufacturing platform.

Responsibilities:

• Lead the design, configuration, installation, and maintenance of automation software (Supervisory Control and Data Acquisition) and associated hardware; including interacting with other teams as necessary.
• Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA systems, data concentration, batch reporting, and data retention.
• Maintains, troubleshoots and modifies the GMP and non-GMP control systems; Systems may include plant wide SCADA, 3rd party local control systems, freezers, air handlers and chillers.
• Prepare scopes of work and manage automation contractors as required to complete required work on within project timelines; determine equipment or system specifications and most cost-effective technology to be implemented.
• Participate in 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).
• Responsible for maintaining procedures to meet GMP requirements, FDA Code of Federal Regulations (CFR’s) and internal company policies.
• Support site-based operations outside business hours as needed
• Other related duties as assigned.

Requirements:

• B.S. degree in Engineering, Computer Science, or related technical field.
• 8 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish.
• Experience programming, troubleshooting, and maintaining site SCADA systems (e.g. FactoryTalk View SE, iFix, Wonderware), site PLC systems (e.g. ControlLogix), site data historian (e.g. FactoryTalk Historian) and developing SQL queries
• Proven experience applying S88 in an automated environment and validation testing
• Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
• Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc.
• 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.
• 10 % travel may be required.

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