Senior Manufacturing Engineer

Gene Fab is seeking a Senior Manufacturing Engineer to lead the identification, implementation, and management of production technology and digital infrastructure across our GMP manufacturing operations. This role will serve as the primary driver of Gene Fab's deployment of innovative technologies (internally developed and integration of external) and it's transition to digital systems (including electronic batch records, process data historians),equipment data integration, and lifecycle management.

The Senior Manufacturing Engineer will act as system owner for critical and specialized manufacturing equipment and computerized systems, owning the lifecycle of critical equipment and systems, from acquisition to offboarding. This role will also support commercial readiness activities, contributing to continued process verification infrastructure and regulatory inspection preparedness as Gene Fab advances through later-stage clinical and commercial readiness.

This is a high-visibility, high-impact individual contributor role. The ideal candidate combines deep GMP manufacturing knowledge with hands-on experience implementing equipment and digital systems in a regulated environment, and thrives in a fast-paced, entrepreneurial setting where they will build and integrate capabilities from the ground up.

This position is offered as a contract engagement with eligibility for conversion to full-time employment based on performance, business needs, and mutual alignment. Gene Fab is committed to investing in high-performing contributors and views this role as a long-term addition to the organization.

Responsibilities:

• Lead and support design, evaluation, selection and implementation of production technologies and equipment that support highly efficient production of Cell and Gene Therapies. This includes novel unit operations and process interface equipment, robotics, physical and digital AI, and other related technologies.
• Lead the evaluation, selection, and implementation of an electronic systems such as batch record (E ) platform to replace paper batch records across all manufacturing processes.
• Establish a process data historian (e.g., AVEVA PI, Influx
  
  DB) to capture and store time-series process and environmental data from manufacturing equipment and cleanroom monitoring systems.

• Develop and execute the equipment data integration strategy, establishing connectivity between GMP instruments (e.g., Miltenyi Prodigy, Cytiva Xuri/XDR/AKTA, Fresenius Kabi Lovo, Sepax, Vi-CELL BLU, Nucleo Counter, Cryo Med controlled-rate freezers, etc...) and centralized data systems.
• Responsible for equipment and systems end to end; from URS, basis of design/risk assessment, detailed design, implementation, commissioning and qualification.
• Evaluate and deploy integration solutions including OPC-UA connections, data bridge PCs, network file shares, and middleware platforms (e.g., Scitara, Tetra Science) based on instrument connectivity capabilities.
• Ensure all implemented systems comply with 21 CFR Part 11, ALCOA+ data integrity principles, and applicable GAMP 5 guidelines.
• Act as system owner for critical and specialized manufacturing equipment from a data and systems perspective, ensuring equipment data outputs are captured, backed up, and accessible for process monitoring and regulatory purposes.
• Own periodic review cadence, audit trail reviews, user access management, and health monitoring system.
• Manage equipment lifecycle from a systems perspective: lead new equipment implementation and commissioning of data connectivity, oversee system retirement and data archival. Physical maintenance, calibration, and qualification remain with Facilities, Validation, and/or Metrology.
• Own the relationship with digital system and integration middleware vendors, managing contracts, upgrades, issue resolution, and roadmap alignment.
• Develop and maintain system-level documentation including user requirements specifications, system configuration documents, and periodic review reports.
• Build the data infrastructure that enables continued process verification (CPV), ensuring process parameters, quality attributes, and environmental data are consolidated and accessible for statistical trending.
• Partner with MSAT to define data extraction and aggregation workflows from E , LIMS, and historian systems to support CPV analysis and reporting.
• Design and implement dashboards and automated reporting tools for real-time manufacturing performance visibility.
• Ensure comprehensive data backup coverage across all instruments, (including those not natively connected to network backup systems such as Uni Trends)
• Support commercial readiness activities by ensuring digital systems and data infrastructure are in place to support process validation lifecycle stages, including Stage 3 (continued process verification).
• Contribute to regulatory inspection readiness by maintaining inspection-ready system documentation, audit trails, and access control records.

Qualifications

• Bachelor's degree in…