Sr. Automation Engineer

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.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• BS/MS in Engineering or a relevant sub-field of engineering.

Technical Experience:

• 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.

Knowledge, Skills, and Abilities:

• 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.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION:

The expected salary range for this position is $114,000 to $150,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Applicants must have current work authorization when accepting a position at Sequoia. Currently, Sequoia is unable to sponsor or take over sponsorship of an employment Visa at this time.