Process Engineer

Summary

Join Sequoia Biotech Consulting, a leading life sciences consultancy, as a Process Engineer. You will contribute to process engineering, development, and technology transfer for mRNA and LNP-related projects. This role involves assisting with equipment qualification, risk assessments, and process improvement initiatives. You will collaborate with internal and external teams, ensuring compliance with cGMP and regulatory standards. The ideal candidate possesses a minimum of 5 years of relevant experience in a cGMP environment and a strong understanding of mRNA and LNP processes. Sequoia offers a competitive salary, comprehensive benefits, flexible work arrangements, and opportunities for professional development.

Requirements

• Bachelor’s degree in Engineering, Bio/Pharma Science, or related technical field of study
• Minimum 5 years of related engineering and/or technical experience
• Background in managing start-up projects and technical background in Manufacturing Science & Technology (MS&T), Engineering, Process Development, Manufacturing, etc
• Experience with cGMP Manufacturing within an FDA-regulated manufacturing company
• Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company
• Knowledge of FDA regulations and guidance or applicable regulatory standards and practices
• 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

Responsibilities

• Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit
• Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE)
• Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements
• Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements
• Provide technical support for the product/process lifecycle and related activities
• Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed
• Provide support for improvement projects regarding processes and systems
• Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable
• Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration)
• Analyze and recommend improved technology to increase quality and efficiency
• Provide technical analysis and support for new or improved process systems
• Facilitate and schedule meetings with subject matter experts across the organization
• Ensure compliance with cGMP, regulatory, and industry standards

Preferred Qualifications

Prior experience with AKTA and Cytiva production equipment used in scale-up

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”