Sr. Automation Engineer

COMPANY DESCRIPTION

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. 
 
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.  

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. 

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. 

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. 

For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com

POSITION OVERVIEW:

Sequoia is seeking an experienced Automation Engineer with validation experience, knowledgeable in mRNA and LNP equipment and processes, to assist with, but not limited to, automation with CSV, life cycle documents, automation SDLC network and IT infrastructure, and distributed control systems including historian and batch software.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• 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.
• Experience with site start-up projects and technical background in Manufacturing Science & Technology (MS&T), Engineering, Process Development, and Manufacturing.
• Development of novel circular mRNA purification and LNP formulation platform for delivery of highly pure drug substance.
• Cell/Gene Therapy production experience in GMP, R&D, and Operations is a MUST.
• Spec equipment, order, set-up, troubleshoot, and maintain nucleic acid production, purification, and characterization equipment for optimal RNA workflow.
• Experience with downstream purification, unit operations, column chromatography, column packing, tangential flow filtration (TFF), depth filtration, and continuous manufacturing.
• Design, lead, and drive experiments for screening, optimization, and scale-up purification of RNA.
• Knowledge of mRNA processes and upstream process equipment (TFF, Chromatography).
• Start-up experience with process equipment.