Process Engineer
| Company | Sequoia Biotech Consulting |
|---|---|
| Location | Belmont, MA, USA |
| Salary | $100000 – $130000 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
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 required.
- 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.
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.
- 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.
Preferred Qualifications
- Prior experience with AKTA and Cytiva production equipment used in scale-up is preferred.