Process Engineer II / III, MSAT

GeneFab • Alameda, CA

15h • $100,000 - $130,000 • Onsite

About The Position

GeneFab is seeking a Process Engineer II / III in Manufacturing Sciences and Technology (MSAT) to support technology transfer, process implementation, and ongoing GMP manufacturing of cell and gene therapy programs. This individual-contributor role serves as a technical owner for internal and client processes moving from development into GMP manufacturing and through the clinical lifecycle. The scope includes autologous and allogeneic cell therapies and viral vector manufacturing. The engineer works with Manufacturing, Process Development, Analytical Development, Quality Control, Quality Assurance, Supply Chain, Facilities, and client technical teams to achieve GMP readiness and reliable batch execution. The level is determined by experience; at level III, the engineer is expected to independently lead technology transfer workstreams and serve as the primary MSAT technical contact for assigned client programs.

The role is based onsite at GeneFab’s Alameda, California facility, with work in office, laboratory, and GMP cleanroom environments. It requires gowning for aseptic processing areas and regular presence on the manufacturing floor. Work may involve BSL-2 materials, cryogenic liquids such as liquid nitrogen, and laboratory chemicals under established safety procedures. Occasional evening, weekend, or holiday support may be required to align with GMP manufacturing schedules. The position requires the ability to stand for extended periods and lift up to 25 pounds.

The anticipated base salary range is $100,000–$130,000. Final level and salary depend on relevant experience, skills, education, and internal equity.

Requirements

• Bachelor’s or Master’s degree in Chemical Engineering, Bioengineering, Biomedical Engineering, Biotechnology, Cell/Molecular Biology, or a related field.
• Process Engineer II: 3–5 years of relevant industry experience with a bachelor’s degree, or 1–3 years with a master’s degree.
• Process Engineer III: 5–8 years of relevant industry experience with a bachelor’s degree, or 3–6 years with a master’s degree.
• Hands-on experience with cell therapy and/or viral vector manufacturing processes in a cGMP environment.
• Demonstrated experience in technology transfer, process implementation, and manufacturing support for clinical or commercial programs.
• Experience with single-use systems and closed or automated cell-processing equipment.
• Working knowledge of cGMP regulations and FDA, EMA, and ICH guidance applicable to cell and gene therapy products.
• Understanding of process lifecycle management from clinical through commercial, including process characterization, control strategy, PPQ, and CPV.
• Proficiency in data analysis and statistical tools such as JMP or Minitab, including interpreting data in a phase-appropriate context and clearly communicating conclusions.
• Strong technical writing skills and experience authoring GMP documentation and investigation reports.
• Strong communication and project management skills, with comfort working directly with client technical teams.
• Ability to stand for extended periods and lift up to 25 pounds.
• Ability to work in office, laboratory, and GMP cleanroom environments; gowning is required for aseptic processing areas.
• Ability to work with BSL-2 materials, cryogenic liquids, and laboratory chemicals under established safety procedures.

Nice To Haves

• Experience across both cell therapy and viral vector manufacturing.
• CDMO experience.

Responsibilities

• Lead or support technology transfer workstreams for internal and client programs, coordinating sending units with receiving units.
• Develop and execute technology transfer plans, including gap assessments, facility fit analyses, and program-aligned timelines.
• Conduct process risk assessments such as FMEA and define mitigation strategies for transfer and scale-up activities.
• Author and review process descriptions, bills of materials, material specifications, engineering run protocols and reports, and technology transfer reports.
• Partner with Manufacturing to translate process descriptions into batch records and SOPs, and review and approve batch records and related GMP documentation.
• Plan and execute engineering and demonstration runs and evaluate results against acceptance criteria to confirm GMP readiness.
• Serve as MSAT process owner for autologous and allogeneic cell therapy processes, including cell selection, activation, transduction, expansion, harvest, formulation, and cryopreservation.
• Implement and support closed and automated processing platforms, including CliniMACS Prodigy, Sepax, Rotea, G-Rex, and controlled-rate freezers.
• Support viral vector process implementation across upstream and downstream unit operations.
• Contribute to the build-out of internal manufacturing platforms, including single-use equipment selection, process fit, and scale-up.
• Provide on-the-floor technical support during GMP manufacturing and troubleshoot process and equipment issues in real time.
• Lead or support deviation investigations, root cause analyses, and CAPAs, including technical assessments of product impact.
• Monitor and trend process parameters, in-process results, and yields to detect drift and identify improvement opportunities.
• Author and assess change controls for process, material, and equipment changes.
• Train Manufacturing staff on new processes, equipment, and technologies.
• Support process characterization studies, including risk-based identification of critical process parameters and their relationship to critical quality attributes.
• Contribute to phase-appropriate control strategies, including in-process controls, proven acceptable ranges, and specifications.
• Support process performance qualification planning and execution, and establishment of continued process verification programs.
• Evaluate manufacturing processes for opportunities to improve robustness, scalability, yield, and cost of goods.
• Design and execute small-scale studies to support investigations and demonstrate proof of concept for proposed process changes.
• Participate in continuous improvement initiatives across MSAT and Manufacturing.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level