GeneFab is seeking a Senior Manufacturing Engineer to lead the identification, implementation, and management of production technology and digital infrastructure across our GMP manufacturing operations.
Requirements
- Lead and support design, evaluation, selection and implementation of production technologies and equipment that support highly efficient production of Cell and Gene Therapies.
- Lead the evaluation, selection, and implementation of an electronic systems such as batch record (EBR) platform to replace paper batch records across all manufacturing processes.
- Establish a process data historian 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 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 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.
- 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 EBR, 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 UniTrends)
- 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.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Stock options
- Paid time off
- Flexible work hours
- Professional development opportunities
