Senior Automation Engineer

Summary

Join Sequoia Biotech Consulting, a leading life sciences consultancy, as an experienced Automation Engineer. You will play a key role in implementing and validating automation systems for mRNA and LNP equipment and processes. Responsibilities include evaluating processes, developing system integration designs, executing application software implementation, and leading testing protocols. This position requires a BS/MS in Engineering, 5+ years of relevant experience, and proven cGMP compliance knowledge. Sequoia offers a competitive salary ($114,000-$150,000), robust benefits, flexible work arrangements (including fully remote options), and career development opportunities. The ideal candidate will possess strong leadership, communication, and problem-solving skills, along with experience in cell/gene therapy production and downstream purification techniques.

Requirements

• BS/MS in Engineering or a relevant sub-field of engineering
• Minimum 5 years of related engineering and/or technical experience required
• 4-7 years of relevant experience within the biotech industry with proven knowledge of current Good Manufacturing Procedures (cGMP) compliance
• Proficient understanding of analog advanced control and batch control
• Proficient knowledge of P&IDs and instrumentation/control equipment in an industrial environment
• Understanding of the control methods, analog and discrete, and the critical components to developing sustainable control algorithms
• Demonstrate leadership in loop checking, startup, troubleshooting, and commissioning support in an industrial environment
• Proficient ability to understand control philosophy and write functional requirement specifications
• Strong leadership, collaboration, communication, prioritization, and problem-solving skills
• Highly motivated, independent, detail-oriented team player with good organization, initiative, and a collaborative attitude is essential
• Excellent computer, verbal, and written communication skills
• Innovative problem-solving skills and an integrated view of business/scientific issues
• Accountable and responsible individual to perform as intended for clients
• Willingness to travel to various clients when needed, with acceptable limitations during noted health pandemics or related constraints
• Experience with site start-up projects and technical background in Manufacturing Science & Technology (MS&T), Engineering, Process Development, and Manufacturing
• Cell/Gene Therapy production experience in GMP, R&D, and Operations is a MUST
• Experience with downstream purification, unit operations, column chromatography, column packing, tangential flow filtration (TFF), depth filtration, and continuous manufacturing
• Knowledge of mRNA processes and upstream process equipment (TFF, Chromatography)
• Start-up experience with process equipment

Responsibilities

• Evaluate various processes to implement optimal configuration changes
• Oversee and assist in the development and review of System Integration Design Specifications for the integration of third-party equipment
• Execute the implementation of application software, device interface, and system integration designs
• Lead the development, review, and execution of Module, Integration, and Customer Acceptance Tests protocols, which cover the testing of the application software, device interface, and system integration implementation
• Assist with installation, commissioning, and startup, system upgrades, and continued process improvement
• Implement control methodology in DCS, PLC, or HMI platforms with a high level of understanding of various programming languages
• Work cross-functionally with Quality, Regulatory, and Manufacturing organizations. May act as a representative in multidisciplinary project teams and present data when necessary
• Provide technical leadership for the execution of projects
• Ensure compliance with cGMP, regulatory, and industry standards
• Knowledgeable in mRNA and LNP equipment and processes
• Development of novel circular mRNA purification and LNP formulation platform for delivery of highly pure drug substance
• Spec equipment, order, set-up, troubleshoot, and maintain nucleic acid production, purification, and characterization equipment for optimal RNA workflow
• Design, lead, and drive experiments for screening, optimization, and scale-up purification of RNA

Preferred Qualifications

Experience with mRNA and LNP equipment and processes

Benefits

• Market competitive base salary and annual incentive plan
• Robust benefit offerings
• Ongoing recognition and career development opportunities
• Generous flexible paid time off program
• Company-paid holidays
• Flexible working hours
• Fully remote work options for most positions and the ability to work “almost anywhere”